Rheumatoid Arthritis

ROME — Osteoarthritis of the knee or hip might hurt like the dickens, but affected patients can take a measure of solace from new evidence that their ailment is associated with less hip fracture.

Preliminary results from a large Swedish population-based study show that an inverse relationship exists between knee or hip osteoarthritis (OA) and incident hip fracture. The OA patients had roughly a 15% lower-than-expected rate of the traumatic injury, Dr. Martin Englund reported at the meeting.

The study captured all 11,901 adult residents of the southernmost county of Sweden who had hip OA, as well as the 23,866 with knee OA.

During the study years of 2004-2007, there were 398 hip fractures among the knee OA group.

This was significantly fewer than the 470 hip fractures that would have been expected based on age- and sex-standardized data from the general population of the county, which contains 1.1 million residents, he reported.

Similarly, there were 233 hip fractures in patients with OA of the hip, compared with an expected 271, noted Dr. Englund, who is affiliated with the department of orthopedics at Lund (Sweden) University and the clinical epidemiology research and training unit at Boston University.

This translates to an observed hip fracture rate in the knee OA group of 763/100,000 per year, compared with an expected rate of 900/100,000 per year.

The observed rate of hip fracture in patients with hip OA was 884/100,000 per year, compared with the expected rate of 1,028 hip fractures per 100,000 per year.

The mechanism responsible for this protective effect remains unclear, according to Dr. Englund, who noted that there are some reports of increased bone mineral density in patients who have hip OA. More frequent obesity among OA patients may possibly also protect against fracture when patients fall—through the extra “padding” in the hip.

Disclosures: Dr. Englund reported having no conflicts of interest. The study was funded by the Swedish Research Council, the Swedish Social Insurance Agency, the Lund University Faculty of Medicine, and Region Skåne, Sweden.

ROME — Osteoarthritis of the knee or hip might hurt like the dickens, but affected patients can take a measure of solace from new evidence that their ailment is associated with less hip fracture.

Preliminary results from a large Swedish population-based study show that an inverse relationship exists between knee or hip osteoarthritis (OA) and incident hip fracture. The OA patients had roughly a 15% lower-than-expected rate of the traumatic injury, Dr. Martin Englund reported at the meeting.

The study captured all 11,901 adult residents of the southernmost county of Sweden who had hip OA, as well as the 23,866 with knee OA.

During the study years of 2004-2007, there were 398 hip fractures among the knee OA group.

This was significantly fewer than the 470 hip fractures that would have been expected based on age- and sex-standardized data from the general population of the county, which contains 1.1 million residents, he reported.

Similarly, there were 233 hip fractures in patients with OA of the hip, compared with an expected 271, noted Dr. Englund, who is affiliated with the department of orthopedics at Lund (Sweden) University and the clinical epidemiology research and training unit at Boston University.

This translates to an observed hip fracture rate in the knee OA group of 763/100,000 per year, compared with an expected rate of 900/100,000 per year.

The observed rate of hip fracture in patients with hip OA was 884/100,000 per year, compared with the expected rate of 1,028 hip fractures per 100,000 per year.

The mechanism responsible for this protective effect remains unclear, according to Dr. Englund, who noted that there are some reports of increased bone mineral density in patients who have hip OA. More frequent obesity among OA patients may possibly also protect against fracture when patients fall—through the extra “padding” in the hip.

Disclosures: Dr. Englund reported having no conflicts of interest. The study was funded by the Swedish Research Council, the Swedish Social Insurance Agency, the Lund University Faculty of Medicine, and Region Skåne, Sweden.

ROME — Osteoarthritis of the knee or hip might hurt like the dickens, but affected patients can take a measure of solace from new evidence that their ailment is associated with less hip fracture.

Preliminary results from a large Swedish population-based study show that an inverse relationship exists between knee or hip osteoarthritis (OA) and incident hip fracture. The OA patients had roughly a 15% lower-than-expected rate of the traumatic injury, Dr. Martin Englund reported at the meeting.

The study captured all 11,901 adult residents of the southernmost county of Sweden who had hip OA, as well as the 23,866 with knee OA.

During the study years of 2004-2007, there were 398 hip fractures among the knee OA group.

This was significantly fewer than the 470 hip fractures that would have been expected based on age- and sex-standardized data from the general population of the county, which contains 1.1 million residents, he reported.

Similarly, there were 233 hip fractures in patients with OA of the hip, compared with an expected 271, noted Dr. Englund, who is affiliated with the department of orthopedics at Lund (Sweden) University and the clinical epidemiology research and training unit at Boston University.

This translates to an observed hip fracture rate in the knee OA group of 763/100,000 per year, compared with an expected rate of 900/100,000 per year.

The observed rate of hip fracture in patients with hip OA was 884/100,000 per year, compared with the expected rate of 1,028 hip fractures per 100,000 per year.

The mechanism responsible for this protective effect remains unclear, according to Dr. Englund, who noted that there are some reports of increased bone mineral density in patients who have hip OA. More frequent obesity among OA patients may possibly also protect against fracture when patients fall—through the extra “padding” in the hip.

Disclosures: Dr. Englund reported having no conflicts of interest. The study was funded by the Swedish Research Council, the Swedish Social Insurance Agency, the Lund University Faculty of Medicine, and Region Skåne, Sweden.

ROME — A tailored combination of cognitive-behavioral therapy and physical exercise training has achieved the largest treatment benefit ever reported for fibromyalgia in a randomized, placebo-controlled clinical trial.

The durability of the results was particularly impressive. The large improvements in psychological and physical functioning that were documented at the end of the 8-week treatment program were maintained at the 6-month follow-up, Saskia van Koulil said.

The success of this customized treatment approach hinged upon a two-stage screening process. First, patients who have had their fibromyalgia for fewer than 5 years and were at high risk of long-term dysfunction were selected because prior studies indicated that such individuals tend to have better treatment outcomes in general.

Within this group of high-risk patients, specific cognitive-behavioral patterns seemed to drive their fibromyalgia pain and disability. It is possible to screen for these patterns of thought and behavior. One school of thought among clinical psychologists, including Ms. van Koulil, holds that there are two main patterns: pain avoidance and pain persistence. The treatment programs for the two are quite different, explained Ms. van Koulil of St. Radboud University Medical Center in Nijmegen, the Netherlands.

The high treatment success rate in this randomized trial validated this concept of the pain-avoidance and pain-persistence fibromyalgia subtypes, she said.

In her experience, close to two-thirds of patients with fibromyalgia of fewer than 5 years' duration have a high-risk profile. This is characterized by high levels of anxiety and/or negative mood on standard measures of distress, worse physical functioning, greater impact of fibromyalgia on daily life, and obvious maladaptive cognitive-behavioral patterns such as high levels of helplessness and worrying. This high-level psychological distress is an indicator of treatment motivation, Ms. van Koulil said.

In the randomized trial, 158 high-risk fibromyalgia patients (95% of whom were women) were evaluated with a brief screening instrument for pain-avoidance behavior. Those with a high score were assigned to the pain-avoidance treatment group or a wait-list control arm, whereas patients with a low score were randomized to the pain-persistence group or the control arm.

The pain-avoidance subtype of fibro-myalgia is often marked by fear of pain, hypervigilance, catastrophizing, and zealous avoidance of pain. The pain-persistence subtype is marked by an overactive life-style and low levels of pain avoidance.

These highly self-demanding patients tend to ignore pain, ignore their physical limits, and display high levels of task persistence. Both subtypes end up via different routes at the same place, which is marked by functional disability, psychologic distress, fatigue, and chronic pain. The pain-persistence group, however, tends to be more physically fit.

Of study participants, 53% were categorized as pain avoidant; 47% were classified in the pain-persistence group.

Patients in both active-treatment arms received 16 twice-weekly treatment sessions in eight-patient groups, each session 4 hours in length, plus homework assignments. The first half of each session was devoted to cognitive-behavioral therapy (CBT), the second half to exercise training. Each exercise session included aerobic exercises, either strength or flexibility training, and relaxation techniques. The patient's significant other attended the 3rd, 9th, and 15th sessions. A booster session was held 3 months after completion of the 8-week program.

The CBT was delivered by therapists with experience in CBT for fibromyalgia and other rheumatologic conditions. Therapy was guided by a written manual. The exercise training was provided by physical therapists.

The pain-avoidance treatment regimen was tailored toward achieving increased daily activities, reduced fear of pain and pain-avoidance behaviors through titrated exposure, and a gradual gain in physical condition. The emphasis in the pain-persistence group was on learning to improve pacing and regulation of activities of daily life and physical exercise, along with altering pain-persistence cognitions.

Five of the six primary outcome end points in the study were changes from baseline in pain, fatigue, functional disability, negative mood, and anxiety as measured on the Impact of Rheumatic Diseases on General Health and Lifestyle scale, which is derived from the Arthritis Impact Measurement Scales (The sixth outcome measure was change in the impact of fibromyalgia on daily life, as assessed by the 10-item Fibromyalgia Impact Questionnaire (FIQ).

The results were striking: In all, 60% of patients in the tailored-therapy arms experienced a clinically significant reduction in the impact of fibromyalgia on daily life, compared with 24% of controls. Of the tailored-therapy patients, 67% had a clinically significant improvement in the physical function domain combining pain, fatigue, and functional disability, compared with 33% of controls. And 62% of tailored-therapy patients demonstrated a clinically significant improvement in psychological function as reflected in reduced scores for negative mood and anxiety, compared with 33% of controls.

The size of the improvements in the various end points was consistently numerically greater in the pain-avoidance group than in the pain-persistence arm, but not statistically significantly so.

Ms. van Koulil said the treatment effect sizes achieved with a tailored approach in this study were much larger than those seen in prior published studies of various one-size-fits-all therapies.

Pain scores (which have a theoretical range of 6-25) went from a mean baseline of 20 in the pain-avoidance treatment arm to 16 at the end of treatment and 17 at 6 months of follow-up. In the pain-persistence arm, pain scores went from a baseline of 19 to 16, then 16 at follow-up. Pain scores were unchanged over time in the control arm.

The impact of fibromyalgia on daily life as assessed by the FIQ (with a theoretical range of 0-100 points) went from a baseline of 66 to 48 at the end of pain-avoidance therapy, with a modest rebound to 50 at 6 months of follow-up. In the pain-persistence treatment arm, scores improved from a baseline of 57 to 47 at treatment's end and 43 at follow-up. Again, scores were flat over time in the control arms.

The encouraging results are welcome because of the dearth of effective treatment options for fibromyalgia. Fibromyalgia has the highest associated financial costs of all chronic pain and rheumatologic conditions, and the disease's negative impact on daily life is often profound, Ms. van Koulil said.

Disclosures: The study was fimded by the Dutch Arthritis Association and the Netherlands Organization for Health Research. Ms. van Koulil reported having no conflicts of interest.

In all, 60% of patients with tailored therapy had a clinically significant reduction in the impact of fibromyalgia on daily life.

Source ©BRANDXPICTURES

ROME — A tailored combination of cognitive-behavioral therapy and physical exercise training has achieved the largest treatment benefit ever reported for fibromyalgia in a randomized, placebo-controlled clinical trial.

The durability of the results was particularly impressive. The large improvements in psychological and physical functioning that were documented at the end of the 8-week treatment program were maintained at the 6-month follow-up, Saskia van Koulil said.

The success of this customized treatment approach hinged upon a two-stage screening process. First, patients who have had their fibromyalgia for fewer than 5 years and were at high risk of long-term dysfunction were selected because prior studies indicated that such individuals tend to have better treatment outcomes in general.

Within this group of high-risk patients, specific cognitive-behavioral patterns seemed to drive their fibromyalgia pain and disability. It is possible to screen for these patterns of thought and behavior. One school of thought among clinical psychologists, including Ms. van Koulil, holds that there are two main patterns: pain avoidance and pain persistence. The treatment programs for the two are quite different, explained Ms. van Koulil of St. Radboud University Medical Center in Nijmegen, the Netherlands.

The high treatment success rate in this randomized trial validated this concept of the pain-avoidance and pain-persistence fibromyalgia subtypes, she said.

In her experience, close to two-thirds of patients with fibromyalgia of fewer than 5 years' duration have a high-risk profile. This is characterized by high levels of anxiety and/or negative mood on standard measures of distress, worse physical functioning, greater impact of fibromyalgia on daily life, and obvious maladaptive cognitive-behavioral patterns such as high levels of helplessness and worrying. This high-level psychological distress is an indicator of treatment motivation, Ms. van Koulil said.

In the randomized trial, 158 high-risk fibromyalgia patients (95% of whom were women) were evaluated with a brief screening instrument for pain-avoidance behavior. Those with a high score were assigned to the pain-avoidance treatment group or a wait-list control arm, whereas patients with a low score were randomized to the pain-persistence group or the control arm.

The pain-avoidance subtype of fibro-myalgia is often marked by fear of pain, hypervigilance, catastrophizing, and zealous avoidance of pain. The pain-persistence subtype is marked by an overactive life-style and low levels of pain avoidance.

These highly self-demanding patients tend to ignore pain, ignore their physical limits, and display high levels of task persistence. Both subtypes end up via different routes at the same place, which is marked by functional disability, psychologic distress, fatigue, and chronic pain. The pain-persistence group, however, tends to be more physically fit.

Of study participants, 53% were categorized as pain avoidant; 47% were classified in the pain-persistence group.

Patients in both active-treatment arms received 16 twice-weekly treatment sessions in eight-patient groups, each session 4 hours in length, plus homework assignments. The first half of each session was devoted to cognitive-behavioral therapy (CBT), the second half to exercise training. Each exercise session included aerobic exercises, either strength or flexibility training, and relaxation techniques. The patient's significant other attended the 3rd, 9th, and 15th sessions. A booster session was held 3 months after completion of the 8-week program.

The CBT was delivered by therapists with experience in CBT for fibromyalgia and other rheumatologic conditions. Therapy was guided by a written manual. The exercise training was provided by physical therapists.

The pain-avoidance treatment regimen was tailored toward achieving increased daily activities, reduced fear of pain and pain-avoidance behaviors through titrated exposure, and a gradual gain in physical condition. The emphasis in the pain-persistence group was on learning to improve pacing and regulation of activities of daily life and physical exercise, along with altering pain-persistence cognitions.

Five of the six primary outcome end points in the study were changes from baseline in pain, fatigue, functional disability, negative mood, and anxiety as measured on the Impact of Rheumatic Diseases on General Health and Lifestyle scale, which is derived from the Arthritis Impact Measurement Scales (The sixth outcome measure was change in the impact of fibromyalgia on daily life, as assessed by the 10-item Fibromyalgia Impact Questionnaire (FIQ).

The results were striking: In all, 60% of patients in the tailored-therapy arms experienced a clinically significant reduction in the impact of fibromyalgia on daily life, compared with 24% of controls. Of the tailored-therapy patients, 67% had a clinically significant improvement in the physical function domain combining pain, fatigue, and functional disability, compared with 33% of controls. And 62% of tailored-therapy patients demonstrated a clinically significant improvement in psychological function as reflected in reduced scores for negative mood and anxiety, compared with 33% of controls.

The size of the improvements in the various end points was consistently numerically greater in the pain-avoidance group than in the pain-persistence arm, but not statistically significantly so.

Ms. van Koulil said the treatment effect sizes achieved with a tailored approach in this study were much larger than those seen in prior published studies of various one-size-fits-all therapies.

Pain scores (which have a theoretical range of 6-25) went from a mean baseline of 20 in the pain-avoidance treatment arm to 16 at the end of treatment and 17 at 6 months of follow-up. In the pain-persistence arm, pain scores went from a baseline of 19 to 16, then 16 at follow-up. Pain scores were unchanged over time in the control arm.

The impact of fibromyalgia on daily life as assessed by the FIQ (with a theoretical range of 0-100 points) went from a baseline of 66 to 48 at the end of pain-avoidance therapy, with a modest rebound to 50 at 6 months of follow-up. In the pain-persistence treatment arm, scores improved from a baseline of 57 to 47 at treatment's end and 43 at follow-up. Again, scores were flat over time in the control arms.

The encouraging results are welcome because of the dearth of effective treatment options for fibromyalgia. Fibromyalgia has the highest associated financial costs of all chronic pain and rheumatologic conditions, and the disease's negative impact on daily life is often profound, Ms. van Koulil said.

Disclosures: The study was fimded by the Dutch Arthritis Association and the Netherlands Organization for Health Research. Ms. van Koulil reported having no conflicts of interest.

In all, 60% of patients with tailored therapy had a clinically significant reduction in the impact of fibromyalgia on daily life.

Source ©BRANDXPICTURES

ROME — A tailored combination of cognitive-behavioral therapy and physical exercise training has achieved the largest treatment benefit ever reported for fibromyalgia in a randomized, placebo-controlled clinical trial.

The durability of the results was particularly impressive. The large improvements in psychological and physical functioning that were documented at the end of the 8-week treatment program were maintained at the 6-month follow-up, Saskia van Koulil said.

The success of this customized treatment approach hinged upon a two-stage screening process. First, patients who have had their fibromyalgia for fewer than 5 years and were at high risk of long-term dysfunction were selected because prior studies indicated that such individuals tend to have better treatment outcomes in general.

Within this group of high-risk patients, specific cognitive-behavioral patterns seemed to drive their fibromyalgia pain and disability. It is possible to screen for these patterns of thought and behavior. One school of thought among clinical psychologists, including Ms. van Koulil, holds that there are two main patterns: pain avoidance and pain persistence. The treatment programs for the two are quite different, explained Ms. van Koulil of St. Radboud University Medical Center in Nijmegen, the Netherlands.

The high treatment success rate in this randomized trial validated this concept of the pain-avoidance and pain-persistence fibromyalgia subtypes, she said.

In her experience, close to two-thirds of patients with fibromyalgia of fewer than 5 years' duration have a high-risk profile. This is characterized by high levels of anxiety and/or negative mood on standard measures of distress, worse physical functioning, greater impact of fibromyalgia on daily life, and obvious maladaptive cognitive-behavioral patterns such as high levels of helplessness and worrying. This high-level psychological distress is an indicator of treatment motivation, Ms. van Koulil said.

In the randomized trial, 158 high-risk fibromyalgia patients (95% of whom were women) were evaluated with a brief screening instrument for pain-avoidance behavior. Those with a high score were assigned to the pain-avoidance treatment group or a wait-list control arm, whereas patients with a low score were randomized to the pain-persistence group or the control arm.

The pain-avoidance subtype of fibro-myalgia is often marked by fear of pain, hypervigilance, catastrophizing, and zealous avoidance of pain. The pain-persistence subtype is marked by an overactive life-style and low levels of pain avoidance.

These highly self-demanding patients tend to ignore pain, ignore their physical limits, and display high levels of task persistence. Both subtypes end up via different routes at the same place, which is marked by functional disability, psychologic distress, fatigue, and chronic pain. The pain-persistence group, however, tends to be more physically fit.

Of study participants, 53% were categorized as pain avoidant; 47% were classified in the pain-persistence group.

Patients in both active-treatment arms received 16 twice-weekly treatment sessions in eight-patient groups, each session 4 hours in length, plus homework assignments. The first half of each session was devoted to cognitive-behavioral therapy (CBT), the second half to exercise training. Each exercise session included aerobic exercises, either strength or flexibility training, and relaxation techniques. The patient's significant other attended the 3rd, 9th, and 15th sessions. A booster session was held 3 months after completion of the 8-week program.

The CBT was delivered by therapists with experience in CBT for fibromyalgia and other rheumatologic conditions. Therapy was guided by a written manual. The exercise training was provided by physical therapists.

The pain-avoidance treatment regimen was tailored toward achieving increased daily activities, reduced fear of pain and pain-avoidance behaviors through titrated exposure, and a gradual gain in physical condition. The emphasis in the pain-persistence group was on learning to improve pacing and regulation of activities of daily life and physical exercise, along with altering pain-persistence cognitions.

Five of the six primary outcome end points in the study were changes from baseline in pain, fatigue, functional disability, negative mood, and anxiety as measured on the Impact of Rheumatic Diseases on General Health and Lifestyle scale, which is derived from the Arthritis Impact Measurement Scales (The sixth outcome measure was change in the impact of fibromyalgia on daily life, as assessed by the 10-item Fibromyalgia Impact Questionnaire (FIQ).

The results were striking: In all, 60% of patients in the tailored-therapy arms experienced a clinically significant reduction in the impact of fibromyalgia on daily life, compared with 24% of controls. Of the tailored-therapy patients, 67% had a clinically significant improvement in the physical function domain combining pain, fatigue, and functional disability, compared with 33% of controls. And 62% of tailored-therapy patients demonstrated a clinically significant improvement in psychological function as reflected in reduced scores for negative mood and anxiety, compared with 33% of controls.

The size of the improvements in the various end points was consistently numerically greater in the pain-avoidance group than in the pain-persistence arm, but not statistically significantly so.

Ms. van Koulil said the treatment effect sizes achieved with a tailored approach in this study were much larger than those seen in prior published studies of various one-size-fits-all therapies.

Pain scores (which have a theoretical range of 6-25) went from a mean baseline of 20 in the pain-avoidance treatment arm to 16 at the end of treatment and 17 at 6 months of follow-up. In the pain-persistence arm, pain scores went from a baseline of 19 to 16, then 16 at follow-up. Pain scores were unchanged over time in the control arm.

The impact of fibromyalgia on daily life as assessed by the FIQ (with a theoretical range of 0-100 points) went from a baseline of 66 to 48 at the end of pain-avoidance therapy, with a modest rebound to 50 at 6 months of follow-up. In the pain-persistence treatment arm, scores improved from a baseline of 57 to 47 at treatment's end and 43 at follow-up. Again, scores were flat over time in the control arms.

The encouraging results are welcome because of the dearth of effective treatment options for fibromyalgia. Fibromyalgia has the highest associated financial costs of all chronic pain and rheumatologic conditions, and the disease's negative impact on daily life is often profound, Ms. van Koulil said.

Disclosures: The study was fimded by the Dutch Arthritis Association and the Netherlands Organization for Health Research. Ms. van Koulil reported having no conflicts of interest.

In all, 60% of patients with tailored therapy had a clinically significant reduction in the impact of fibromyalgia on daily life.

Source ©BRANDXPICTURES

The Ankylosing Spondylitis Disease Activity Score now has established, clinically relevant cutoff values for disease activity states and improvement scores.

The validated criteria will be useful in clinical practice, epidemiologic studies, and clinical trials, according to Dr. Pedro Machado, a rheumatologist who is now a doctoral student at Leiden (the Netherlands) University Medical Center and Coimbra (Portugal) University Hospital, and who presented the validation findings.

The development and characteristics of the Ankylosing Spondylitis Disease Activity Score (ASDAS) have recently been described (Ann. Rheum. Dis. 2009;68:18–24;1811–8). The score is based on questions about back pain, duration of morning stiffness, and peripheral pain/swelling and scores from the patient global assessment, as well as findings from an acute phase reactant (either C-reactive protein level or erythrocyte sedimentation rate). However, the clinically relevant cutoff values for disease activity states and improvement for this composite index had not yet been determined. The ASDAS was developed by the Assessment of Spondyloarthritis International Society (ASAS).

Dr. Machado and his colleagues performed ROC (receiver operating characteristic) analysis against several external criteria to determine the optimal cutoffs, using data from the large Norwegian disease-modifying antirheumatic drug (NOR-DMARD) registry. Included in the registry are data on patients with ankylosing spondylitis who started treatment with either a conventional DMARD or a tumor necrosis factor blocker. The investigators cross-validated those data with information from the ASSERT (Ankylosing Spondylitis Study for the Evaluation of Recombinant Infliximab Therapy) patient database.

ASAS members voted to define distinct disease activity states: inactive disease, and moderate, high, and very high disease activity. In the ROC analysis, both patient and physician global assessments at predefined levels were used as external constructs for inactive disease, to separate moderate from high disease activity, and for very high disease activity, respectively. ASAS partial remission was also used as a criterion for determining the cutoff for inactive disease. Based on these findings, the investigators established the following cutoff ASDAS scores for separating inactive disease, moderate, high, and very high disease activity: 1.3, 2.1, and 3.5, respectively.

Selected cutoffs for improvement scores were a change of at least 1.1 units for clinically important improvement, and a change of at least 2.0 units for major improvement, Dr. Machado explained.

The cutoff values then were validated in an 80% random sample of the 6-month ASSERT (n = 219). Findings showed a clear shift of treated patients from higher and toward lower disease activity states. Moreover, the longitudinal differences between the infliximab and placebo groups clearly discriminated between the two treatment arms.

“Results of our cross-validation strongly supported these cutoffs,” he said. The scores perform better than existing criteria for evaluating clinical disease activity and improvement. The ASDAS is a composite index with continuous measure ment properties that avoids redundancy and allows for more thorough evaluation of disease activity, he said.

Disclosures: Dr. Machado reported that he has received grant or research support in the form of a fellowship from ARTICULUM. Other researchers involved with this study reported receiving grant or research support from Centocor Inc. and/or serving as a consultant or employee for Centocor.

To see an interview with Dr. Machado, go to

Source Heidi Splete/Elsevier Global Medical Newswww.youtube/elsglobalmedicalnews

The Ankylosing Spondylitis Disease Activity Score now has established, clinically relevant cutoff values for disease activity states and improvement scores.

The validated criteria will be useful in clinical practice, epidemiologic studies, and clinical trials, according to Dr. Pedro Machado, a rheumatologist who is now a doctoral student at Leiden (the Netherlands) University Medical Center and Coimbra (Portugal) University Hospital, and who presented the validation findings.

The development and characteristics of the Ankylosing Spondylitis Disease Activity Score (ASDAS) have recently been described (Ann. Rheum. Dis. 2009;68:18–24;1811–8). The score is based on questions about back pain, duration of morning stiffness, and peripheral pain/swelling and scores from the patient global assessment, as well as findings from an acute phase reactant (either C-reactive protein level or erythrocyte sedimentation rate). However, the clinically relevant cutoff values for disease activity states and improvement for this composite index had not yet been determined. The ASDAS was developed by the Assessment of Spondyloarthritis International Society (ASAS).

Dr. Machado and his colleagues performed ROC (receiver operating characteristic) analysis against several external criteria to determine the optimal cutoffs, using data from the large Norwegian disease-modifying antirheumatic drug (NOR-DMARD) registry. Included in the registry are data on patients with ankylosing spondylitis who started treatment with either a conventional DMARD or a tumor necrosis factor blocker. The investigators cross-validated those data with information from the ASSERT (Ankylosing Spondylitis Study for the Evaluation of Recombinant Infliximab Therapy) patient database.

ASAS members voted to define distinct disease activity states: inactive disease, and moderate, high, and very high disease activity. In the ROC analysis, both patient and physician global assessments at predefined levels were used as external constructs for inactive disease, to separate moderate from high disease activity, and for very high disease activity, respectively. ASAS partial remission was also used as a criterion for determining the cutoff for inactive disease. Based on these findings, the investigators established the following cutoff ASDAS scores for separating inactive disease, moderate, high, and very high disease activity: 1.3, 2.1, and 3.5, respectively.

Selected cutoffs for improvement scores were a change of at least 1.1 units for clinically important improvement, and a change of at least 2.0 units for major improvement, Dr. Machado explained.

The cutoff values then were validated in an 80% random sample of the 6-month ASSERT (n = 219). Findings showed a clear shift of treated patients from higher and toward lower disease activity states. Moreover, the longitudinal differences between the infliximab and placebo groups clearly discriminated between the two treatment arms.

“Results of our cross-validation strongly supported these cutoffs,” he said. The scores perform better than existing criteria for evaluating clinical disease activity and improvement. The ASDAS is a composite index with continuous measure ment properties that avoids redundancy and allows for more thorough evaluation of disease activity, he said.

Disclosures: Dr. Machado reported that he has received grant or research support in the form of a fellowship from ARTICULUM. Other researchers involved with this study reported receiving grant or research support from Centocor Inc. and/or serving as a consultant or employee for Centocor.

To see an interview with Dr. Machado, go to

Source Heidi Splete/Elsevier Global Medical Newswww.youtube/elsglobalmedicalnews

The Ankylosing Spondylitis Disease Activity Score now has established, clinically relevant cutoff values for disease activity states and improvement scores.

The validated criteria will be useful in clinical practice, epidemiologic studies, and clinical trials, according to Dr. Pedro Machado, a rheumatologist who is now a doctoral student at Leiden (the Netherlands) University Medical Center and Coimbra (Portugal) University Hospital, and who presented the validation findings.

The development and characteristics of the Ankylosing Spondylitis Disease Activity Score (ASDAS) have recently been described (Ann. Rheum. Dis. 2009;68:18–24;1811–8). The score is based on questions about back pain, duration of morning stiffness, and peripheral pain/swelling and scores from the patient global assessment, as well as findings from an acute phase reactant (either C-reactive protein level or erythrocyte sedimentation rate). However, the clinically relevant cutoff values for disease activity states and improvement for this composite index had not yet been determined. The ASDAS was developed by the Assessment of Spondyloarthritis International Society (ASAS).

Dr. Machado and his colleagues performed ROC (receiver operating characteristic) analysis against several external criteria to determine the optimal cutoffs, using data from the large Norwegian disease-modifying antirheumatic drug (NOR-DMARD) registry. Included in the registry are data on patients with ankylosing spondylitis who started treatment with either a conventional DMARD or a tumor necrosis factor blocker. The investigators cross-validated those data with information from the ASSERT (Ankylosing Spondylitis Study for the Evaluation of Recombinant Infliximab Therapy) patient database.

ASAS members voted to define distinct disease activity states: inactive disease, and moderate, high, and very high disease activity. In the ROC analysis, both patient and physician global assessments at predefined levels were used as external constructs for inactive disease, to separate moderate from high disease activity, and for very high disease activity, respectively. ASAS partial remission was also used as a criterion for determining the cutoff for inactive disease. Based on these findings, the investigators established the following cutoff ASDAS scores for separating inactive disease, moderate, high, and very high disease activity: 1.3, 2.1, and 3.5, respectively.

Selected cutoffs for improvement scores were a change of at least 1.1 units for clinically important improvement, and a change of at least 2.0 units for major improvement, Dr. Machado explained.

The cutoff values then were validated in an 80% random sample of the 6-month ASSERT (n = 219). Findings showed a clear shift of treated patients from higher and toward lower disease activity states. Moreover, the longitudinal differences between the infliximab and placebo groups clearly discriminated between the two treatment arms.

“Results of our cross-validation strongly supported these cutoffs,” he said. The scores perform better than existing criteria for evaluating clinical disease activity and improvement. The ASDAS is a composite index with continuous measure ment properties that avoids redundancy and allows for more thorough evaluation of disease activity, he said.

Disclosures: Dr. Machado reported that he has received grant or research support in the form of a fellowship from ARTICULUM. Other researchers involved with this study reported receiving grant or research support from Centocor Inc. and/or serving as a consultant or employee for Centocor.

To see an interview with Dr. Machado, go to

Source Heidi Splete/Elsevier Global Medical Newswww.youtube/elsglobalmedicalnews

Major Finding: A panel organized by the ASAS and EULAR issued recommendations for the management of ankylosing spondylitis.

Data Source: A series of 11 specific management recommendations developed by a 25-member panel that met for 2 days in February in Zurich.

Disclosures: Dr. Braun has received research support from, been a consultant to, and served as a speaker for Abbott Laboratories, Amgen Inc., Bristol-Myers Squibb Co., Centocor Inc., Merck/Schering-Plough Pharmaceuticals, Merck Sharp & Dohme Corp., Novartis, Pfizer Inc./Wyeth, and Roche.

ROME — Revised recommendations for the management of ankylosing spondylitis from two international societies set tumor necrosis factor inhibitors as the cornerstone of treatment for patients who fail to have an adequate response to treatment with nonsteroidal anti-inflammatory drugs.

The new recommendations also put new emphasis on the extra-articular manifestations of ankylosing spondylitis (AS)—including psoriasis, uveitis, and inflammatory bowel disease (IBD)—and stress that these manifestations should be managed in collaboration with other specialists, along with recognition that AS patients also face increased risks for cardiovascular disease and osteoporosis, Dr. Jürgen Braun said at the annual congress.

AS patients who present with psoriasis, uveitis, or inflammatory bowel disease may do better on a monoclonal antibody–based TNF inhibitor because those forms seem to work better on the extra-articular manifestations than do soluble receptor–based TNF inhibitors, Dr. Braun said in an interview.

On the other hand, soluble receptor–based anti-TNF drugs appear to be somewhat safer, in that they appear to pose a reduced risk for activating either latent tuberculosis or herpes zoster infections, he said.

In the treatment of AS, the main difference “compared with rheumatoid arthritis is that conventional disease-modifying antirheumatic drugs [DMARDs] do not work for axial symptoms,” which exist in the majority of AS patients. “This makes TNF inhibitors almost first-line agents, after [NSAIDs]. All TNF inhibitors work similarly well for the spine, peripheral joints, and entheses.” For AS patients whose major problem is peripheral joint disease, a conventional DMARD—specifically sulfasalazine—can be effective, said Dr. Braun, director of the Center for Rheumatic Diseases in Herne, Germany.

The new treatment guidelines complement the new classification criteria for AS and axial spondyloarthritis that were published by the ASAS (Assessment of Spondyloarthritis International Association) last year (Ann. Rheum. Dis. 2009;68:777–83).

The new classification criteria mean that rheumatologists can “treat when they see inflammation on MRI” instead of having to wait for patients to develop radiographic changes, Dr. Braun noted.

The new classification criteria—coupled with the new treatment recommendations—put treatment on a faster track, and give physicians backup to put those AS patients who don't respond within a few weeks to NSAID therapy on a TNF inhibitor relatively early in the course of their disease.

A panel of 18 rheumatologists, two orthopedic surgeons, one physiotherapist, and four patients formed by ASAS and EULAR (European League Against Rheumatism) devised the new treatment recommendations over 2 days in February in Zurich.

The panel of physicians based their decisions on a review of the published literature since 2005.

The recommendations consist of 11 specific AS management directives that cover everything from general treatment to surgery, and rule out other causes in patients who do respond to standard care.

They will appear in an article the EULAR journal, Annals of the Rheumatic Diseases, in the near future.

To view an interview with Dr. Braun, go to www.youtube.com/elsglobalmedicalnews

Certain subsets of AS patients with uveitis, psoriasis, or IBD do better on monoclonal antibody-based TNF blockers.

Source DR. BRAUN

Major Finding: A panel organized by the ASAS and EULAR issued recommendations for the management of ankylosing spondylitis.

Data Source: A series of 11 specific management recommendations developed by a 25-member panel that met for 2 days in February in Zurich.

Disclosures: Dr. Braun has received research support from, been a consultant to, and served as a speaker for Abbott Laboratories, Amgen Inc., Bristol-Myers Squibb Co., Centocor Inc., Merck/Schering-Plough Pharmaceuticals, Merck Sharp & Dohme Corp., Novartis, Pfizer Inc./Wyeth, and Roche.

ROME — Revised recommendations for the management of ankylosing spondylitis from two international societies set tumor necrosis factor inhibitors as the cornerstone of treatment for patients who fail to have an adequate response to treatment with nonsteroidal anti-inflammatory drugs.

The new recommendations also put new emphasis on the extra-articular manifestations of ankylosing spondylitis (AS)—including psoriasis, uveitis, and inflammatory bowel disease (IBD)—and stress that these manifestations should be managed in collaboration with other specialists, along with recognition that AS patients also face increased risks for cardiovascular disease and osteoporosis, Dr. Jürgen Braun said at the annual congress.

AS patients who present with psoriasis, uveitis, or inflammatory bowel disease may do better on a monoclonal antibody–based TNF inhibitor because those forms seem to work better on the extra-articular manifestations than do soluble receptor–based TNF inhibitors, Dr. Braun said in an interview.

On the other hand, soluble receptor–based anti-TNF drugs appear to be somewhat safer, in that they appear to pose a reduced risk for activating either latent tuberculosis or herpes zoster infections, he said.

In the treatment of AS, the main difference “compared with rheumatoid arthritis is that conventional disease-modifying antirheumatic drugs [DMARDs] do not work for axial symptoms,” which exist in the majority of AS patients. “This makes TNF inhibitors almost first-line agents, after [NSAIDs]. All TNF inhibitors work similarly well for the spine, peripheral joints, and entheses.” For AS patients whose major problem is peripheral joint disease, a conventional DMARD—specifically sulfasalazine—can be effective, said Dr. Braun, director of the Center for Rheumatic Diseases in Herne, Germany.

The new treatment guidelines complement the new classification criteria for AS and axial spondyloarthritis that were published by the ASAS (Assessment of Spondyloarthritis International Association) last year (Ann. Rheum. Dis. 2009;68:777–83).

The new classification criteria mean that rheumatologists can “treat when they see inflammation on MRI” instead of having to wait for patients to develop radiographic changes, Dr. Braun noted.

The new classification criteria—coupled with the new treatment recommendations—put treatment on a faster track, and give physicians backup to put those AS patients who don't respond within a few weeks to NSAID therapy on a TNF inhibitor relatively early in the course of their disease.

A panel of 18 rheumatologists, two orthopedic surgeons, one physiotherapist, and four patients formed by ASAS and EULAR (European League Against Rheumatism) devised the new treatment recommendations over 2 days in February in Zurich.

The panel of physicians based their decisions on a review of the published literature since 2005.

The recommendations consist of 11 specific AS management directives that cover everything from general treatment to surgery, and rule out other causes in patients who do respond to standard care.

They will appear in an article the EULAR journal, Annals of the Rheumatic Diseases, in the near future.

To view an interview with Dr. Braun, go to www.youtube.com/elsglobalmedicalnews

Certain subsets of AS patients with uveitis, psoriasis, or IBD do better on monoclonal antibody-based TNF blockers.

Source DR. BRAUN

Major Finding: A panel organized by the ASAS and EULAR issued recommendations for the management of ankylosing spondylitis.

Data Source: A series of 11 specific management recommendations developed by a 25-member panel that met for 2 days in February in Zurich.

Disclosures: Dr. Braun has received research support from, been a consultant to, and served as a speaker for Abbott Laboratories, Amgen Inc., Bristol-Myers Squibb Co., Centocor Inc., Merck/Schering-Plough Pharmaceuticals, Merck Sharp & Dohme Corp., Novartis, Pfizer Inc./Wyeth, and Roche.

ROME — Revised recommendations for the management of ankylosing spondylitis from two international societies set tumor necrosis factor inhibitors as the cornerstone of treatment for patients who fail to have an adequate response to treatment with nonsteroidal anti-inflammatory drugs.

The new recommendations also put new emphasis on the extra-articular manifestations of ankylosing spondylitis (AS)—including psoriasis, uveitis, and inflammatory bowel disease (IBD)—and stress that these manifestations should be managed in collaboration with other specialists, along with recognition that AS patients also face increased risks for cardiovascular disease and osteoporosis, Dr. Jürgen Braun said at the annual congress.

AS patients who present with psoriasis, uveitis, or inflammatory bowel disease may do better on a monoclonal antibody–based TNF inhibitor because those forms seem to work better on the extra-articular manifestations than do soluble receptor–based TNF inhibitors, Dr. Braun said in an interview.

On the other hand, soluble receptor–based anti-TNF drugs appear to be somewhat safer, in that they appear to pose a reduced risk for activating either latent tuberculosis or herpes zoster infections, he said.

In the treatment of AS, the main difference “compared with rheumatoid arthritis is that conventional disease-modifying antirheumatic drugs [DMARDs] do not work for axial symptoms,” which exist in the majority of AS patients. “This makes TNF inhibitors almost first-line agents, after [NSAIDs]. All TNF inhibitors work similarly well for the spine, peripheral joints, and entheses.” For AS patients whose major problem is peripheral joint disease, a conventional DMARD—specifically sulfasalazine—can be effective, said Dr. Braun, director of the Center for Rheumatic Diseases in Herne, Germany.

The new treatment guidelines complement the new classification criteria for AS and axial spondyloarthritis that were published by the ASAS (Assessment of Spondyloarthritis International Association) last year (Ann. Rheum. Dis. 2009;68:777–83).

The new classification criteria mean that rheumatologists can “treat when they see inflammation on MRI” instead of having to wait for patients to develop radiographic changes, Dr. Braun noted.

The new classification criteria—coupled with the new treatment recommendations—put treatment on a faster track, and give physicians backup to put those AS patients who don't respond within a few weeks to NSAID therapy on a TNF inhibitor relatively early in the course of their disease.

A panel of 18 rheumatologists, two orthopedic surgeons, one physiotherapist, and four patients formed by ASAS and EULAR (European League Against Rheumatism) devised the new treatment recommendations over 2 days in February in Zurich.

The panel of physicians based their decisions on a review of the published literature since 2005.

The recommendations consist of 11 specific AS management directives that cover everything from general treatment to surgery, and rule out other causes in patients who do respond to standard care.

They will appear in an article the EULAR journal, Annals of the Rheumatic Diseases, in the near future.

To view an interview with Dr. Braun, go to www.youtube.com/elsglobalmedicalnews

Certain subsets of AS patients with uveitis, psoriasis, or IBD do better on monoclonal antibody-based TNF blockers.

Source DR. BRAUN

Major Finding: The proposed ACR/EULAR cut point for “definite RA” may be held at 6, whereas 3 may be an appropriate cut point for “probable RA.”

Data Source: A cohort of 566 patients with early undifferentiated arthritis.

Disclosures: Dr. Visser said that he had no relevant financial disclosures to make.

The revised classification criteria for rheumatoid arthritis that were developed jointly by the American College of Rheumatology and the European League Against Rheumatism are valid to predict future persistent arthritis and joint erosions in patients with early undifferentiated arthritis, judging from results from a large study.

“Methotrexate is the cornerstone of RA management and frequently initiated as the first [disease-modifying antirheumatic drug] if the suspicion for RA is raised,” lead author Dr. Henk Visser said in an interview with Rheumatology News.

“However, the new ACR/EULAR criteria were not validated against what RA is considered to be: persistent and erosive arthritis,” according to Dr. Visser.

For the study, the researchers validated the new ACR/EULAR criteria for their ability to predict persistent and erosive arthritis in an existing early arthritis cohort of 566 patients who were followed for 2 years (Arthritis Rheum. 2002;46:357–65).

They were included in the current study if at baseline they had had arthritis of at least one joint, arthritis that was not explained by another diagnosis, and no joint erosions on x-ray, and if they had also completed 2 years of follow-up.

The data were presented by Jaap Fransen, Ph.D., of St. Radboud University Medical Centre Nijmegen (the Netherlands).

The mean age of patients at baseline was 52 years; 56% were female.

Dr. Visser, a rheumatologist at Rijnstate Hospital in Arnhem, the Netherlands, said in an interview that at 2 years of follow-up, 45% of patients had persistent arthritis, and 48% of them had erosions.

At baseline, patients had a median of two swollen joints, 23% were positive for IgM rheumatoid factor, 18% were positive for anticitrullinated protein antibodies, 25% had symptoms lasting longer than 6 weeks, and the patients' median erythrocyte sedimentation rate was 26 mm/h.

The researchers found that joint involvement, serology, symptoms lasting longer than 6 weeks, and elevated acute phase reactants were significantly associated with persistent arthritis, whereas joint involvement and serology were significantly associated with erosions.

The strength of the 0–10 “risk” score of the revised classification criteria was significantly associated with persistent arthritis (odds ratio, 1.6) and erosions (OR, 1.8), with areas under the ROC curve of .79 and .81, respectively.

Patients with a risk score of 6 or higher at baseline had a .74 probability to develop persistent arthritis at year 2, and given persistence there was a .68 probability to develop erosions. The discriminative ability of the new ACR/EULAR criteria and the earlier prediction model developed for early diagnosis of RA by Dr. Visser and his colleagues are comparable.

The previous ACR classification criteria performed much more poorly.

Dr. Visser and his associates concluded that the proposed cut point for “definite RA” may be held at a risk score of 6, whereas a score of 3 may be an appropriate cut point for “probable RA,” according to Dr. Visser and associates.

Disclosures: Dr. Visser said that he had no relevant financial disclosures to make.

Effusion and bone edema can be seen on this wrist MRI of a patient with rheumatoid arthritis.

Source ©2010 Kevin Shea, M.D/Custom Medical Stock Photo, All Rights Reserved

Major Finding: The proposed ACR/EULAR cut point for “definite RA” may be held at 6, whereas 3 may be an appropriate cut point for “probable RA.”

Data Source: A cohort of 566 patients with early undifferentiated arthritis.

Disclosures: Dr. Visser said that he had no relevant financial disclosures to make.

The revised classification criteria for rheumatoid arthritis that were developed jointly by the American College of Rheumatology and the European League Against Rheumatism are valid to predict future persistent arthritis and joint erosions in patients with early undifferentiated arthritis, judging from results from a large study.

“Methotrexate is the cornerstone of RA management and frequently initiated as the first [disease-modifying antirheumatic drug] if the suspicion for RA is raised,” lead author Dr. Henk Visser said in an interview with Rheumatology News.

“However, the new ACR/EULAR criteria were not validated against what RA is considered to be: persistent and erosive arthritis,” according to Dr. Visser.

For the study, the researchers validated the new ACR/EULAR criteria for their ability to predict persistent and erosive arthritis in an existing early arthritis cohort of 566 patients who were followed for 2 years (Arthritis Rheum. 2002;46:357–65).

They were included in the current study if at baseline they had had arthritis of at least one joint, arthritis that was not explained by another diagnosis, and no joint erosions on x-ray, and if they had also completed 2 years of follow-up.

The data were presented by Jaap Fransen, Ph.D., of St. Radboud University Medical Centre Nijmegen (the Netherlands).

The mean age of patients at baseline was 52 years; 56% were female.

Dr. Visser, a rheumatologist at Rijnstate Hospital in Arnhem, the Netherlands, said in an interview that at 2 years of follow-up, 45% of patients had persistent arthritis, and 48% of them had erosions.

At baseline, patients had a median of two swollen joints, 23% were positive for IgM rheumatoid factor, 18% were positive for anticitrullinated protein antibodies, 25% had symptoms lasting longer than 6 weeks, and the patients' median erythrocyte sedimentation rate was 26 mm/h.

The researchers found that joint involvement, serology, symptoms lasting longer than 6 weeks, and elevated acute phase reactants were significantly associated with persistent arthritis, whereas joint involvement and serology were significantly associated with erosions.

The strength of the 0–10 “risk” score of the revised classification criteria was significantly associated with persistent arthritis (odds ratio, 1.6) and erosions (OR, 1.8), with areas under the ROC curve of .79 and .81, respectively.

Patients with a risk score of 6 or higher at baseline had a .74 probability to develop persistent arthritis at year 2, and given persistence there was a .68 probability to develop erosions. The discriminative ability of the new ACR/EULAR criteria and the earlier prediction model developed for early diagnosis of RA by Dr. Visser and his colleagues are comparable.

The previous ACR classification criteria performed much more poorly.

Dr. Visser and his associates concluded that the proposed cut point for “definite RA” may be held at a risk score of 6, whereas a score of 3 may be an appropriate cut point for “probable RA,” according to Dr. Visser and associates.

Disclosures: Dr. Visser said that he had no relevant financial disclosures to make.

Effusion and bone edema can be seen on this wrist MRI of a patient with rheumatoid arthritis.

Source ©2010 Kevin Shea, M.D/Custom Medical Stock Photo, All Rights Reserved

Major Finding: The proposed ACR/EULAR cut point for “definite RA” may be held at 6, whereas 3 may be an appropriate cut point for “probable RA.”

Data Source: A cohort of 566 patients with early undifferentiated arthritis.

Disclosures: Dr. Visser said that he had no relevant financial disclosures to make.

The revised classification criteria for rheumatoid arthritis that were developed jointly by the American College of Rheumatology and the European League Against Rheumatism are valid to predict future persistent arthritis and joint erosions in patients with early undifferentiated arthritis, judging from results from a large study.

“Methotrexate is the cornerstone of RA management and frequently initiated as the first [disease-modifying antirheumatic drug] if the suspicion for RA is raised,” lead author Dr. Henk Visser said in an interview with Rheumatology News.

“However, the new ACR/EULAR criteria were not validated against what RA is considered to be: persistent and erosive arthritis,” according to Dr. Visser.

For the study, the researchers validated the new ACR/EULAR criteria for their ability to predict persistent and erosive arthritis in an existing early arthritis cohort of 566 patients who were followed for 2 years (Arthritis Rheum. 2002;46:357–65).

They were included in the current study if at baseline they had had arthritis of at least one joint, arthritis that was not explained by another diagnosis, and no joint erosions on x-ray, and if they had also completed 2 years of follow-up.

The data were presented by Jaap Fransen, Ph.D., of St. Radboud University Medical Centre Nijmegen (the Netherlands).

The mean age of patients at baseline was 52 years; 56% were female.

Dr. Visser, a rheumatologist at Rijnstate Hospital in Arnhem, the Netherlands, said in an interview that at 2 years of follow-up, 45% of patients had persistent arthritis, and 48% of them had erosions.

At baseline, patients had a median of two swollen joints, 23% were positive for IgM rheumatoid factor, 18% were positive for anticitrullinated protein antibodies, 25% had symptoms lasting longer than 6 weeks, and the patients' median erythrocyte sedimentation rate was 26 mm/h.

The researchers found that joint involvement, serology, symptoms lasting longer than 6 weeks, and elevated acute phase reactants were significantly associated with persistent arthritis, whereas joint involvement and serology were significantly associated with erosions.

The strength of the 0–10 “risk” score of the revised classification criteria was significantly associated with persistent arthritis (odds ratio, 1.6) and erosions (OR, 1.8), with areas under the ROC curve of .79 and .81, respectively.

Patients with a risk score of 6 or higher at baseline had a .74 probability to develop persistent arthritis at year 2, and given persistence there was a .68 probability to develop erosions. The discriminative ability of the new ACR/EULAR criteria and the earlier prediction model developed for early diagnosis of RA by Dr. Visser and his colleagues are comparable.

The previous ACR classification criteria performed much more poorly.

Dr. Visser and his associates concluded that the proposed cut point for “definite RA” may be held at a risk score of 6, whereas a score of 3 may be an appropriate cut point for “probable RA,” according to Dr. Visser and associates.

Disclosures: Dr. Visser said that he had no relevant financial disclosures to make.

Effusion and bone edema can be seen on this wrist MRI of a patient with rheumatoid arthritis.

Source ©2010 Kevin Shea, M.D/Custom Medical Stock Photo, All Rights Reserved

Higher-than-standard doses of rituximab improved clinical response rates in patients with rheumatoid arthritis who had an incomplete B-lymphocyte depletion as determined by highly sensitive flow cytometry, judging from results from a small study.

“Not only is B-cell depletion important in determining clinical response, it can be enhanced by increasing the dose of rituximab,” according to Dr. Edward Vital of the U.K. National Institute for Health Research's Leeds (England) Musculoskeletal Biomedical Research Unit.

Rituximab is administered as two 1-g doses, “but a significant proportion [of patients] fail to achieve a EULAR response after standard therapy,” he said.

Dr. Vital and his associates used highly sensitive flow cytometry to identify 26 patients with active RA and incomplete deletion 2 weeks after they received an initial 1-g dose of rituximab. The patients were then randomized 1:1 to a total of either 2 g or 3 g rituximab.

At the end of 40 weeks, a significantly higher proportion of patients who received 3 g of rituximab had EULAR moderate/good response rates, compared with their counterparts who received 2 g (92% vs. 54%, respectively). Data from 1 year of follow-up on 20 of the patients showed EULAR moderate/good responses in 67% of patients who received 3 g vs. 27% in those who received 2 g.

Disclosures: Dr. Vital disclosed that he received research support from Roche to conduct the study.

Higher-than-standard doses of rituximab improved clinical response rates in patients with rheumatoid arthritis who had an incomplete B-lymphocyte depletion as determined by highly sensitive flow cytometry, judging from results from a small study.

“Not only is B-cell depletion important in determining clinical response, it can be enhanced by increasing the dose of rituximab,” according to Dr. Edward Vital of the U.K. National Institute for Health Research's Leeds (England) Musculoskeletal Biomedical Research Unit.

Rituximab is administered as two 1-g doses, “but a significant proportion [of patients] fail to achieve a EULAR response after standard therapy,” he said.

Dr. Vital and his associates used highly sensitive flow cytometry to identify 26 patients with active RA and incomplete deletion 2 weeks after they received an initial 1-g dose of rituximab. The patients were then randomized 1:1 to a total of either 2 g or 3 g rituximab.

At the end of 40 weeks, a significantly higher proportion of patients who received 3 g of rituximab had EULAR moderate/good response rates, compared with their counterparts who received 2 g (92% vs. 54%, respectively). Data from 1 year of follow-up on 20 of the patients showed EULAR moderate/good responses in 67% of patients who received 3 g vs. 27% in those who received 2 g.

Disclosures: Dr. Vital disclosed that he received research support from Roche to conduct the study.

Higher-than-standard doses of rituximab improved clinical response rates in patients with rheumatoid arthritis who had an incomplete B-lymphocyte depletion as determined by highly sensitive flow cytometry, judging from results from a small study.

“Not only is B-cell depletion important in determining clinical response, it can be enhanced by increasing the dose of rituximab,” according to Dr. Edward Vital of the U.K. National Institute for Health Research's Leeds (England) Musculoskeletal Biomedical Research Unit.

Rituximab is administered as two 1-g doses, “but a significant proportion [of patients] fail to achieve a EULAR response after standard therapy,” he said.

Dr. Vital and his associates used highly sensitive flow cytometry to identify 26 patients with active RA and incomplete deletion 2 weeks after they received an initial 1-g dose of rituximab. The patients were then randomized 1:1 to a total of either 2 g or 3 g rituximab.

At the end of 40 weeks, a significantly higher proportion of patients who received 3 g of rituximab had EULAR moderate/good response rates, compared with their counterparts who received 2 g (92% vs. 54%, respectively). Data from 1 year of follow-up on 20 of the patients showed EULAR moderate/good responses in 67% of patients who received 3 g vs. 27% in those who received 2 g.

Disclosures: Dr. Vital disclosed that he received research support from Roche to conduct the study.

ROME — Tumor necrosis factor inhibitors significantly reduced joint damage progression in patients with rheumatoid arthritis after 2 years, compared with conventional treatment, based on data from a nationwide observational cohort study.

The progression rate during anti-TNF treatment was reduced by 61%, compared with usual treatment with disease-modifying antirheumatic drugs, said Dr. Lykke Ørnbjerg of Copenhagen University Hospital in Hvidovre, Denmark.

Data from real-life studies of TNF inhibitors to prevent disease progression in RA patients are limited, the researchers noted. They reviewed data from 522 RA patients with an average age of 54 years and average disease duration of 5 years. Most (76%) of the patients were women, 80% were rheumatoid factor positive, 65% were anti–cyclic citrullinated peptide antibody positive, and 27% were smokers.

Conventional radiographs were taken of the patients' hands and wrists at three time points: approximately 2 years before starting TNF inhibitors (time point A), at about the start of TNF inhibitor therapy (time point B), and approximately 2 years after the start of treatment with a TNF inhibitor (time point C).

On three measurements of disease progression (total van der Heijde–Sharp scores, erosion, and joint-space narrowing), the difference in progression was significantly higher between time points A and B (treatment with DMARDs), compared with time points B and C (treatment with a TNF inhibitor). The mean total van der Heijde–Sharp scores between time points A and B vs. B and C were 2.1 vs. 0.67, respectively. The mean erosion scores were 1.04 vs. 0.36, respectively, and the mean joint-space narrowing scores were 1 vs. 0.31, respectively.

The percentage of patients who showed progression of RA was 59% between time points A and B, compared with 31% between time points B and C. The mean value on the 28-joint disease activity score (DAS28) was 4.4 at time point A, 5.0 at time point B, and 3.1 at time point C.

At time point A, 45% of the patients received methotrexate, 22% sulphasalazine, 12% hydroxychloroquine, and 5% leflunomide. Another 6% received other treatments, and 10% received no DMARDs. At time point B, 61% of the patients received infliximab, 24% received adalimumab, and 15% received etanercept. The patients were selected from DANBIO, an ongoing nationwide registry of rheumatology patients in Denmark.

The data show that “even in 'real-life' practice, … treatment with a [TNF inhibitor] halts radiographic progression in the majority of RA patients when they switch from DMARDs,” Dr. Ørnbjerg said.

Disclosure: Dr. Ørnbjerg reported that she had no financial conflicts of interest to disclose. She reported that Centocor Inc. sponsored the data analysis.

To watch an interview of Dr. Ørnbjerg, go to www.youtube.com/elsglobalmedicalnews

Dr. Lykke Ørnbjerg said that the data showing TNF inhibitors slow progression are great news for clinicians who treat RA patients routinely.

Source Heidi Splete/Elsevier Global Medical News

ROME — Tumor necrosis factor inhibitors significantly reduced joint damage progression in patients with rheumatoid arthritis after 2 years, compared with conventional treatment, based on data from a nationwide observational cohort study.

The progression rate during anti-TNF treatment was reduced by 61%, compared with usual treatment with disease-modifying antirheumatic drugs, said Dr. Lykke Ørnbjerg of Copenhagen University Hospital in Hvidovre, Denmark.

Data from real-life studies of TNF inhibitors to prevent disease progression in RA patients are limited, the researchers noted. They reviewed data from 522 RA patients with an average age of 54 years and average disease duration of 5 years. Most (76%) of the patients were women, 80% were rheumatoid factor positive, 65% were anti–cyclic citrullinated peptide antibody positive, and 27% were smokers.

Conventional radiographs were taken of the patients' hands and wrists at three time points: approximately 2 years before starting TNF inhibitors (time point A), at about the start of TNF inhibitor therapy (time point B), and approximately 2 years after the start of treatment with a TNF inhibitor (time point C).

On three measurements of disease progression (total van der Heijde–Sharp scores, erosion, and joint-space narrowing), the difference in progression was significantly higher between time points A and B (treatment with DMARDs), compared with time points B and C (treatment with a TNF inhibitor). The mean total van der Heijde–Sharp scores between time points A and B vs. B and C were 2.1 vs. 0.67, respectively. The mean erosion scores were 1.04 vs. 0.36, respectively, and the mean joint-space narrowing scores were 1 vs. 0.31, respectively.

The percentage of patients who showed progression of RA was 59% between time points A and B, compared with 31% between time points B and C. The mean value on the 28-joint disease activity score (DAS28) was 4.4 at time point A, 5.0 at time point B, and 3.1 at time point C.

At time point A, 45% of the patients received methotrexate, 22% sulphasalazine, 12% hydroxychloroquine, and 5% leflunomide. Another 6% received other treatments, and 10% received no DMARDs. At time point B, 61% of the patients received infliximab, 24% received adalimumab, and 15% received etanercept. The patients were selected from DANBIO, an ongoing nationwide registry of rheumatology patients in Denmark.

The data show that “even in 'real-life' practice, … treatment with a [TNF inhibitor] halts radiographic progression in the majority of RA patients when they switch from DMARDs,” Dr. Ørnbjerg said.

Disclosure: Dr. Ørnbjerg reported that she had no financial conflicts of interest to disclose. She reported that Centocor Inc. sponsored the data analysis.

To watch an interview of Dr. Ørnbjerg, go to www.youtube.com/elsglobalmedicalnews

Dr. Lykke Ørnbjerg said that the data showing TNF inhibitors slow progression are great news for clinicians who treat RA patients routinely.

Source Heidi Splete/Elsevier Global Medical News

ROME — Tumor necrosis factor inhibitors significantly reduced joint damage progression in patients with rheumatoid arthritis after 2 years, compared with conventional treatment, based on data from a nationwide observational cohort study.

The progression rate during anti-TNF treatment was reduced by 61%, compared with usual treatment with disease-modifying antirheumatic drugs, said Dr. Lykke Ørnbjerg of Copenhagen University Hospital in Hvidovre, Denmark.

Data from real-life studies of TNF inhibitors to prevent disease progression in RA patients are limited, the researchers noted. They reviewed data from 522 RA patients with an average age of 54 years and average disease duration of 5 years. Most (76%) of the patients were women, 80% were rheumatoid factor positive, 65% were anti–cyclic citrullinated peptide antibody positive, and 27% were smokers.

Conventional radiographs were taken of the patients' hands and wrists at three time points: approximately 2 years before starting TNF inhibitors (time point A), at about the start of TNF inhibitor therapy (time point B), and approximately 2 years after the start of treatment with a TNF inhibitor (time point C).

On three measurements of disease progression (total van der Heijde–Sharp scores, erosion, and joint-space narrowing), the difference in progression was significantly higher between time points A and B (treatment with DMARDs), compared with time points B and C (treatment with a TNF inhibitor). The mean total van der Heijde–Sharp scores between time points A and B vs. B and C were 2.1 vs. 0.67, respectively. The mean erosion scores were 1.04 vs. 0.36, respectively, and the mean joint-space narrowing scores were 1 vs. 0.31, respectively.

The percentage of patients who showed progression of RA was 59% between time points A and B, compared with 31% between time points B and C. The mean value on the 28-joint disease activity score (DAS28) was 4.4 at time point A, 5.0 at time point B, and 3.1 at time point C.

At time point A, 45% of the patients received methotrexate, 22% sulphasalazine, 12% hydroxychloroquine, and 5% leflunomide. Another 6% received other treatments, and 10% received no DMARDs. At time point B, 61% of the patients received infliximab, 24% received adalimumab, and 15% received etanercept. The patients were selected from DANBIO, an ongoing nationwide registry of rheumatology patients in Denmark.

The data show that “even in 'real-life' practice, … treatment with a [TNF inhibitor] halts radiographic progression in the majority of RA patients when they switch from DMARDs,” Dr. Ørnbjerg said.

Disclosure: Dr. Ørnbjerg reported that she had no financial conflicts of interest to disclose. She reported that Centocor Inc. sponsored the data analysis.

To watch an interview of Dr. Ørnbjerg, go to www.youtube.com/elsglobalmedicalnews

Dr. Lykke Ørnbjerg said that the data showing TNF inhibitors slow progression are great news for clinicians who treat RA patients routinely.

Source Heidi Splete/Elsevier Global Medical News

ROCKVILLE, MD. — Chronic back pain is an enormously heterogenous and common disorder that might better be examined in observational “Framingham-like studies” than in randomized, controlled clinical trials.

The recommendation was proposed by several presenters at the workshop sponsored by the National Center for Complementary and Alternative Medicine (NCCAM), a division of the National Institutes of Health.

“I think this is the right time to be talking about this problem. The NIH has certainly been urged by our leader, Dr. Francis Collins, to worry about research of relevance to health policy, and I can't think of a single issue that has as much resonance or potential implications for health policy as this one,” NCCAM director Josephine Briggs said.

Dr. Briggs also noted, “This is not my area, but as I've learned more about back pain over the last year, I have been absolutely blown away by the magnitude of this problem and the enormous clinical difficulties in bringing relief to most patients suffering from chronic back pain.… This is a totally pervasive, a huge driver of health costs, and frankly, I think a problem for which we only have a small number of satisfactory clinical solutions, so I think it's incredibly important that we talk about it.”

There was agreement among participants that chronic back pain is not simply a multifaceted biological problem, but also a psychosocial one. And as such, there is little correlation between physical findings on imaging or other studies and the degree to which a patient perceives pain or experiences functional impairment. Participants also generally agreed that current treatments, including opioids and surgical approaches, are ineffective in a large proportion of patients and have been associated with harm as well.

The extensive heterogeneity in causes, presentations, and functional impact of chronic back pain has made it impossible to compare studies on the problem and determine the extent to which results from any given study can be extrapolated to another, speakers agreed.

Indeed, even the most commonly used definition of “chronic”—pain lasting longer than 3 or 6 months—is limiting in that it doesn't account for other parameters such as pain intensity, associated psychological dysfunction, or degree of functional impairment, noted Michael Von Korff, Sc.D., senior investigator at Group Health Research Institute, Seattle.

He described an alternative “prognostic risk score” that would not only classify patients with back pain but would also help to determine their probability of future clinically significant back pain. The score, derived from a study of 1,213 primary care back pain patients, utilizes measurements of degrees of pain intensity, interference with activities, persistence, number of pain sites, and depression to define risk levels corresponding to a 50% and an 80% probability of future clinically significant pain (Pain 2005;117:304–13).

Such an “empirically grounded” approach, he said, could help distinguish patients at low risk who could be managed conservatively from those at greater risk for whom intervention could be initiated early, rather than waiting for the passage of time until they meet the “chronic” criteria. Moreover, “it avoids labeling patients as hopeless, with immutable back pain, when change for the better is always possible and often likely.”

William Maixner, D.D.S., Ph.D., professor and director of the Center for Neurosensory Disorders at the University of North Carolina School of Dentistry, Chapel Hill, said that a study he's heading in patients with temporomandibular joint (TMJ) disorders could also serve as a model for studying chronic back pain.

The 7-year Orofacial Pain: Prospective Evaluation and Risk Assessment (OPPERA), funded by the National Institute of Dental and Craniofacial Research (NIDCR), is the first-ever large, prospective clinical study in the field of chronic pain. Begun in 2005, it enrolled 3,276 initially pain-free adults, and is following them with the aim of identifying underlying pathophysiological, psychological, and genetic risk factors that predict who will go on to develop TMJ disorders.

Michele Crites Battié, Ph.D., of the University of Alberta, Edmonton, called into question whether the outcome measures that have been used so far in back pain studies are actually the most relevant and appropriate for ascertaining clinically meaningful treatment effects. For example, should studies assess mean changes in intervention versus control groups, or measure the difference in percent achieving a clinically meaningful threshold? And beyond that, is the data point being measured one that is meaningful to the patient?

Dr. Gary Franklin, a research professor in environmental and occupational health sciences at the University of Washington, Seattle, said the Food and Drug Administration uses only pain as a primary outcome measure for drug trials, with function and quality of life as secondary outcomes.

Several speakers questioned whether the randomized clinical trial, widely considered the “gold standard” type of study for the efficacy of drugs, is really the best type of trial to examine aspects of such a heterogenous problem as chronic back pain, and whether longitudinal observational “Framingham-like” study might be more appropriate to determine what happens to patients with chronic back pain over time.

In an interview, workshop cochair Dr. Partap Khalsa, program officer of the division of intramural research at NCCAM, noted that the best clinical guidelines currently available for managing chronic low back pain are those developed jointly by the American College of Physicians and the American Pain Society. They advise clinicians to conduct a focused history and physical to help determine etiology, and only perform diagnostic imaging in selected patients with severe or progressive neurologic deficits or in whom serious underlying conditions are suspected based on the history and physical exam (Ann. Intern. Med. 2007;147:478–91).

For the 80%–90% of patients with chronic back pain for whom no specific cause can be found, the guidelines advise that physicians educate patients about appropriate self-care and prescribe acetaminophen or nonsteroidal anti-inflammatory agents as first-line therapy. For patients in whom pain persists, nonpharmacologic approaches such as exercise and spinal manipulation may be tried, along with other “interdisciplinary” approaches such as acupuncture, massage therapy, yoga, cognitive-behavioral therapy, or progressive relaxation therapy.

Disclosures: Dr. Khalsa and Dr. Briggs are government employees with no financial conflicts. Dr. von Korff said he received funding only from the NIH, and Dr. Franklin and Dr. Battié stated that they have no disclosures. Dr. Maixner is a cofounder, officer, and equity shareholder in Algynomics Inc.

ROCKVILLE, MD. — Chronic back pain is an enormously heterogenous and common disorder that might better be examined in observational “Framingham-like studies” than in randomized, controlled clinical trials.

The recommendation was proposed by several presenters at the workshop sponsored by the National Center for Complementary and Alternative Medicine (NCCAM), a division of the National Institutes of Health.

“I think this is the right time to be talking about this problem. The NIH has certainly been urged by our leader, Dr. Francis Collins, to worry about research of relevance to health policy, and I can't think of a single issue that has as much resonance or potential implications for health policy as this one,” NCCAM director Josephine Briggs said.

Dr. Briggs also noted, “This is not my area, but as I've learned more about back pain over the last year, I have been absolutely blown away by the magnitude of this problem and the enormous clinical difficulties in bringing relief to most patients suffering from chronic back pain.… This is a totally pervasive, a huge driver of health costs, and frankly, I think a problem for which we only have a small number of satisfactory clinical solutions, so I think it's incredibly important that we talk about it.”

There was agreement among participants that chronic back pain is not simply a multifaceted biological problem, but also a psychosocial one. And as such, there is little correlation between physical findings on imaging or other studies and the degree to which a patient perceives pain or experiences functional impairment. Participants also generally agreed that current treatments, including opioids and surgical approaches, are ineffective in a large proportion of patients and have been associated with harm as well.

The extensive heterogeneity in causes, presentations, and functional impact of chronic back pain has made it impossible to compare studies on the problem and determine the extent to which results from any given study can be extrapolated to another, speakers agreed.

Indeed, even the most commonly used definition of “chronic”—pain lasting longer than 3 or 6 months—is limiting in that it doesn't account for other parameters such as pain intensity, associated psychological dysfunction, or degree of functional impairment, noted Michael Von Korff, Sc.D., senior investigator at Group Health Research Institute, Seattle.

He described an alternative “prognostic risk score” that would not only classify patients with back pain but would also help to determine their probability of future clinically significant back pain. The score, derived from a study of 1,213 primary care back pain patients, utilizes measurements of degrees of pain intensity, interference with activities, persistence, number of pain sites, and depression to define risk levels corresponding to a 50% and an 80% probability of future clinically significant pain (Pain 2005;117:304–13).

Such an “empirically grounded” approach, he said, could help distinguish patients at low risk who could be managed conservatively from those at greater risk for whom intervention could be initiated early, rather than waiting for the passage of time until they meet the “chronic” criteria. Moreover, “it avoids labeling patients as hopeless, with immutable back pain, when change for the better is always possible and often likely.”

William Maixner, D.D.S., Ph.D., professor and director of the Center for Neurosensory Disorders at the University of North Carolina School of Dentistry, Chapel Hill, said that a study he's heading in patients with temporomandibular joint (TMJ) disorders could also serve as a model for studying chronic back pain.

The 7-year Orofacial Pain: Prospective Evaluation and Risk Assessment (OPPERA), funded by the National Institute of Dental and Craniofacial Research (NIDCR), is the first-ever large, prospective clinical study in the field of chronic pain. Begun in 2005, it enrolled 3,276 initially pain-free adults, and is following them with the aim of identifying underlying pathophysiological, psychological, and genetic risk factors that predict who will go on to develop TMJ disorders.

Michele Crites Battié, Ph.D., of the University of Alberta, Edmonton, called into question whether the outcome measures that have been used so far in back pain studies are actually the most relevant and appropriate for ascertaining clinically meaningful treatment effects. For example, should studies assess mean changes in intervention versus control groups, or measure the difference in percent achieving a clinically meaningful threshold? And beyond that, is the data point being measured one that is meaningful to the patient?

Dr. Gary Franklin, a research professor in environmental and occupational health sciences at the University of Washington, Seattle, said the Food and Drug Administration uses only pain as a primary outcome measure for drug trials, with function and quality of life as secondary outcomes.

Several speakers questioned whether the randomized clinical trial, widely considered the “gold standard” type of study for the efficacy of drugs, is really the best type of trial to examine aspects of such a heterogenous problem as chronic back pain, and whether longitudinal observational “Framingham-like” study might be more appropriate to determine what happens to patients with chronic back pain over time.

In an interview, workshop cochair Dr. Partap Khalsa, program officer of the division of intramural research at NCCAM, noted that the best clinical guidelines currently available for managing chronic low back pain are those developed jointly by the American College of Physicians and the American Pain Society. They advise clinicians to conduct a focused history and physical to help determine etiology, and only perform diagnostic imaging in selected patients with severe or progressive neurologic deficits or in whom serious underlying conditions are suspected based on the history and physical exam (Ann. Intern. Med. 2007;147:478–91).

For the 80%–90% of patients with chronic back pain for whom no specific cause can be found, the guidelines advise that physicians educate patients about appropriate self-care and prescribe acetaminophen or nonsteroidal anti-inflammatory agents as first-line therapy. For patients in whom pain persists, nonpharmacologic approaches such as exercise and spinal manipulation may be tried, along with other “interdisciplinary” approaches such as acupuncture, massage therapy, yoga, cognitive-behavioral therapy, or progressive relaxation therapy.

Disclosures: Dr. Khalsa and Dr. Briggs are government employees with no financial conflicts. Dr. von Korff said he received funding only from the NIH, and Dr. Franklin and Dr. Battié stated that they have no disclosures. Dr. Maixner is a cofounder, officer, and equity shareholder in Algynomics Inc.

ROCKVILLE, MD. — Chronic back pain is an enormously heterogenous and common disorder that might better be examined in observational “Framingham-like studies” than in randomized, controlled clinical trials.

The recommendation was proposed by several presenters at the workshop sponsored by the National Center for Complementary and Alternative Medicine (NCCAM), a division of the National Institutes of Health.

“I think this is the right time to be talking about this problem. The NIH has certainly been urged by our leader, Dr. Francis Collins, to worry about research of relevance to health policy, and I can't think of a single issue that has as much resonance or potential implications for health policy as this one,” NCCAM director Josephine Briggs said.

Dr. Briggs also noted, “This is not my area, but as I've learned more about back pain over the last year, I have been absolutely blown away by the magnitude of this problem and the enormous clinical difficulties in bringing relief to most patients suffering from chronic back pain.… This is a totally pervasive, a huge driver of health costs, and frankly, I think a problem for which we only have a small number of satisfactory clinical solutions, so I think it's incredibly important that we talk about it.”

There was agreement among participants that chronic back pain is not simply a multifaceted biological problem, but also a psychosocial one. And as such, there is little correlation between physical findings on imaging or other studies and the degree to which a patient perceives pain or experiences functional impairment. Participants also generally agreed that current treatments, including opioids and surgical approaches, are ineffective in a large proportion of patients and have been associated with harm as well.

The extensive heterogeneity in causes, presentations, and functional impact of chronic back pain has made it impossible to compare studies on the problem and determine the extent to which results from any given study can be extrapolated to another, speakers agreed.

Indeed, even the most commonly used definition of “chronic”—pain lasting longer than 3 or 6 months—is limiting in that it doesn't account for other parameters such as pain intensity, associated psychological dysfunction, or degree of functional impairment, noted Michael Von Korff, Sc.D., senior investigator at Group Health Research Institute, Seattle.

He described an alternative “prognostic risk score” that would not only classify patients with back pain but would also help to determine their probability of future clinically significant back pain. The score, derived from a study of 1,213 primary care back pain patients, utilizes measurements of degrees of pain intensity, interference with activities, persistence, number of pain sites, and depression to define risk levels corresponding to a 50% and an 80% probability of future clinically significant pain (Pain 2005;117:304–13).

Such an “empirically grounded” approach, he said, could help distinguish patients at low risk who could be managed conservatively from those at greater risk for whom intervention could be initiated early, rather than waiting for the passage of time until they meet the “chronic” criteria. Moreover, “it avoids labeling patients as hopeless, with immutable back pain, when change for the better is always possible and often likely.”

William Maixner, D.D.S., Ph.D., professor and director of the Center for Neurosensory Disorders at the University of North Carolina School of Dentistry, Chapel Hill, said that a study he's heading in patients with temporomandibular joint (TMJ) disorders could also serve as a model for studying chronic back pain.

The 7-year Orofacial Pain: Prospective Evaluation and Risk Assessment (OPPERA), funded by the National Institute of Dental and Craniofacial Research (NIDCR), is the first-ever large, prospective clinical study in the field of chronic pain. Begun in 2005, it enrolled 3,276 initially pain-free adults, and is following them with the aim of identifying underlying pathophysiological, psychological, and genetic risk factors that predict who will go on to develop TMJ disorders.

Michele Crites Battié, Ph.D., of the University of Alberta, Edmonton, called into question whether the outcome measures that have been used so far in back pain studies are actually the most relevant and appropriate for ascertaining clinically meaningful treatment effects. For example, should studies assess mean changes in intervention versus control groups, or measure the difference in percent achieving a clinically meaningful threshold? And beyond that, is the data point being measured one that is meaningful to the patient?

Dr. Gary Franklin, a research professor in environmental and occupational health sciences at the University of Washington, Seattle, said the Food and Drug Administration uses only pain as a primary outcome measure for drug trials, with function and quality of life as secondary outcomes.

Several speakers questioned whether the randomized clinical trial, widely considered the “gold standard” type of study for the efficacy of drugs, is really the best type of trial to examine aspects of such a heterogenous problem as chronic back pain, and whether longitudinal observational “Framingham-like” study might be more appropriate to determine what happens to patients with chronic back pain over time.

In an interview, workshop cochair Dr. Partap Khalsa, program officer of the division of intramural research at NCCAM, noted that the best clinical guidelines currently available for managing chronic low back pain are those developed jointly by the American College of Physicians and the American Pain Society. They advise clinicians to conduct a focused history and physical to help determine etiology, and only perform diagnostic imaging in selected patients with severe or progressive neurologic deficits or in whom serious underlying conditions are suspected based on the history and physical exam (Ann. Intern. Med. 2007;147:478–91).

For the 80%–90% of patients with chronic back pain for whom no specific cause can be found, the guidelines advise that physicians educate patients about appropriate self-care and prescribe acetaminophen or nonsteroidal anti-inflammatory agents as first-line therapy. For patients in whom pain persists, nonpharmacologic approaches such as exercise and spinal manipulation may be tried, along with other “interdisciplinary” approaches such as acupuncture, massage therapy, yoga, cognitive-behavioral therapy, or progressive relaxation therapy.

Disclosures: Dr. Khalsa and Dr. Briggs are government employees with no financial conflicts. Dr. von Korff said he received funding only from the NIH, and Dr. Franklin and Dr. Battié stated that they have no disclosures. Dr. Maixner is a cofounder, officer, and equity shareholder in Algynomics Inc.

CHICAGO — On balance, the news about joint replacement innovations for people with rheumatoid arthritis is good.

New lumbar artificial disks, new ankle implants, customized patient instrumentation, and computer-assisted surgical planning offer options that patients with RA-destroyed joints lacked even a decade ago. The unfortunate flip sides of these advances are aggressive and sometimes misleading direct-to-consumer marketing, and occasional unfavorable biological responses to even the newest implant materials.

The field of orthopedic surgery has benefited from “a lot of great science,” said presenter Dr. William Bugbee, an orthopedic surgeon with the Scripps Institute in La Jolla, Calif. Robust innovation has lead to “constant introduction of new technology.”

In the half century since British orthopedic surgeon Sir John Charnley pioneered modern total hip replacement, joint replacement has become one of the most common and successful interventions for arthritis, said Dr. Bugbee. Joint-specific arthroplasty is now available for hips, knees, shoulders, ankles, elbows, the small joints of the feet and hands, and the lumbar and cervical spines.

Spinal disk replacement is now an alternative to spinal fusion, although its efficacy is unproven, said Dr. Bugbee. The objective is to preserve motion, particularly in the cervical spine; for every level that is fused, the patient loses about 15% of motion. The levels above and below also come under greater stress and tend to degenerate.

Shoulder arthroplasties are often performed on patients with RA. The functional outcomes are acceptable and provide pain relief, but fall short of restoring normal shoulder function, said Dr. Bugbee. “Few people can play tennis” following shoulder arthroplasty, he said. The results depend on the integrity of the rotator cuff. A recent innovation is the reverse shoulder arthroplasty, which accommodates a deficient rotator cuff to allow better function of the shoulder after replacement.

Ankle arthroplasty remains the most common operation for arthritis, and is another area of new design. It presents a particular design challenge because the biological ankle has only 9 cm

Arthroplasties of the hip and/or knee have become common and successful surgical interventions for arthritis, and the need for them is growing with the population. It has been estimated that by 2030, the U.S. population will need 2.3 million knee replacements per year. “There's not enough manpower to do all that work,” said Dr. Bugbee. Technical skill is the single most important factor in success.

The appropriate patient age for joint replacement now ranges from the 40s through the 90s said Dr. Bugbee. Although the intervention was originally conceived to relieve pain for elderly, low-demand patients, it is now expected to bring both pain relief and functional improvement. But it is not without risk: Dr. Bugbee estimated that 90-day mortality after surgery is less than 1%, but deep vein thrombosis occurs in 10%-40% of cases. Dislocation rates are 0%-10% because of larger ball and socket joints. Dr. Bugbee estimated that infection occurs in 0.3%-3% of operations.

There are also functional limitations after joint replacement. “A good hip replacement is tantamount to a normal joint,” said Dr. Bugbee. “Unfortunately, the knee is not the same. It is a much more complex joint.”

One area of concern is biological response to implant materials. Microscopic wear debris can be shed by the articulating surfaces. The polyethylene plastic in some implants can cause a granulomatous response, and an osteolytic response in the bone. In metal-on-metal joints, a tiny amount of wear debris may cause severe early osteoarthritis. Ceramic-to-ceramic hip joints have a wear rate about 50 times less than that of conventional polyethylene joints, but they may squeak.

Direct-to-consumer advertising campaigns have promoted minimally invasive surgery, but smaller incisions are not correlated with better outcome, said Dr. Bugbee. They may even have a higher complication rate.

“The next innovation is so-called customized patient instrumentation,” said Dr. Bugbee. The surgery can actually be computer modeled in advance, and can incorporate instruments that are custom built to fit the individual patient's joints. The surgery is then more accelerated and more precise.

Moderator Dr. John J. Cush of Baylor University Medical Center in Dallas, asked, “When patients have bilateral knees, or right and left knees, one of the things I've noticed over the years [is that] they'll always say, 'My right (or my left) is the best one.' They always have an ipsilateral evaluation and a preference. Is there a good reason for that?”

“No. I've seen the same thing. I cannot for the life of me figure it out,” said Dr. Bugbee.

Disclosures: Dr. Bugbee disclosed research grants from Zimmer Inc., Smith & Nephew Inc., and Depuy Inc. Dr. Cush disclosed consulting fees or other remuneration from Centocor Inc., Abbott Laboratories, UCB, Pfizer Inc., Wyeth/Amgen, and Roche, and research grants from Genentech Inc., Pfizer, UCB, Roche, and Celgene Corp.

CHICAGO — On balance, the news about joint replacement innovations for people with rheumatoid arthritis is good.

New lumbar artificial disks, new ankle implants, customized patient instrumentation, and computer-assisted surgical planning offer options that patients with RA-destroyed joints lacked even a decade ago. The unfortunate flip sides of these advances are aggressive and sometimes misleading direct-to-consumer marketing, and occasional unfavorable biological responses to even the newest implant materials.

The field of orthopedic surgery has benefited from “a lot of great science,” said presenter Dr. William Bugbee, an orthopedic surgeon with the Scripps Institute in La Jolla, Calif. Robust innovation has lead to “constant introduction of new technology.”

In the half century since British orthopedic surgeon Sir John Charnley pioneered modern total hip replacement, joint replacement has become one of the most common and successful interventions for arthritis, said Dr. Bugbee. Joint-specific arthroplasty is now available for hips, knees, shoulders, ankles, elbows, the small joints of the feet and hands, and the lumbar and cervical spines.

Spinal disk replacement is now an alternative to spinal fusion, although its efficacy is unproven, said Dr. Bugbee. The objective is to preserve motion, particularly in the cervical spine; for every level that is fused, the patient loses about 15% of motion. The levels above and below also come under greater stress and tend to degenerate.

Shoulder arthroplasties are often performed on patients with RA. The functional outcomes are acceptable and provide pain relief, but fall short of restoring normal shoulder function, said Dr. Bugbee. “Few people can play tennis” following shoulder arthroplasty, he said. The results depend on the integrity of the rotator cuff. A recent innovation is the reverse shoulder arthroplasty, which accommodates a deficient rotator cuff to allow better function of the shoulder after replacement.

Ankle arthroplasty remains the most common operation for arthritis, and is another area of new design. It presents a particular design challenge because the biological ankle has only 9 cm

Arthroplasties of the hip and/or knee have become common and successful surgical interventions for arthritis, and the need for them is growing with the population. It has been estimated that by 2030, the U.S. population will need 2.3 million knee replacements per year. “There's not enough manpower to do all that work,” said Dr. Bugbee. Technical skill is the single most important factor in success.

The appropriate patient age for joint replacement now ranges from the 40s through the 90s said Dr. Bugbee. Although the intervention was originally conceived to relieve pain for elderly, low-demand patients, it is now expected to bring both pain relief and functional improvement. But it is not without risk: Dr. Bugbee estimated that 90-day mortality after surgery is less than 1%, but deep vein thrombosis occurs in 10%-40% of cases. Dislocation rates are 0%-10% because of larger ball and socket joints. Dr. Bugbee estimated that infection occurs in 0.3%-3% of operations.

There are also functional limitations after joint replacement. “A good hip replacement is tantamount to a normal joint,” said Dr. Bugbee. “Unfortunately, the knee is not the same. It is a much more complex joint.”

One area of concern is biological response to implant materials. Microscopic wear debris can be shed by the articulating surfaces. The polyethylene plastic in some implants can cause a granulomatous response, and an osteolytic response in the bone. In metal-on-metal joints, a tiny amount of wear debris may cause severe early osteoarthritis. Ceramic-to-ceramic hip joints have a wear rate about 50 times less than that of conventional polyethylene joints, but they may squeak.

Direct-to-consumer advertising campaigns have promoted minimally invasive surgery, but smaller incisions are not correlated with better outcome, said Dr. Bugbee. They may even have a higher complication rate.

“The next innovation is so-called customized patient instrumentation,” said Dr. Bugbee. The surgery can actually be computer modeled in advance, and can incorporate instruments that are custom built to fit the individual patient's joints. The surgery is then more accelerated and more precise.

Moderator Dr. John J. Cush of Baylor University Medical Center in Dallas, asked, “When patients have bilateral knees, or right and left knees, one of the things I've noticed over the years [is that] they'll always say, 'My right (or my left) is the best one.' They always have an ipsilateral evaluation and a preference. Is there a good reason for that?”

“No. I've seen the same thing. I cannot for the life of me figure it out,” said Dr. Bugbee.

Disclosures: Dr. Bugbee disclosed research grants from Zimmer Inc., Smith & Nephew Inc., and Depuy Inc. Dr. Cush disclosed consulting fees or other remuneration from Centocor Inc., Abbott Laboratories, UCB, Pfizer Inc., Wyeth/Amgen, and Roche, and research grants from Genentech Inc., Pfizer, UCB, Roche, and Celgene Corp.

CHICAGO — On balance, the news about joint replacement innovations for people with rheumatoid arthritis is good.

New lumbar artificial disks, new ankle implants, customized patient instrumentation, and computer-assisted surgical planning offer options that patients with RA-destroyed joints lacked even a decade ago. The unfortunate flip sides of these advances are aggressive and sometimes misleading direct-to-consumer marketing, and occasional unfavorable biological responses to even the newest implant materials.

The field of orthopedic surgery has benefited from “a lot of great science,” said presenter Dr. William Bugbee, an orthopedic surgeon with the Scripps Institute in La Jolla, Calif. Robust innovation has lead to “constant introduction of new technology.”

In the half century since British orthopedic surgeon Sir John Charnley pioneered modern total hip replacement, joint replacement has become one of the most common and successful interventions for arthritis, said Dr. Bugbee. Joint-specific arthroplasty is now available for hips, knees, shoulders, ankles, elbows, the small joints of the feet and hands, and the lumbar and cervical spines.

Spinal disk replacement is now an alternative to spinal fusion, although its efficacy is unproven, said Dr. Bugbee. The objective is to preserve motion, particularly in the cervical spine; for every level that is fused, the patient loses about 15% of motion. The levels above and below also come under greater stress and tend to degenerate.

Shoulder arthroplasties are often performed on patients with RA. The functional outcomes are acceptable and provide pain relief, but fall short of restoring normal shoulder function, said Dr. Bugbee. “Few people can play tennis” following shoulder arthroplasty, he said. The results depend on the integrity of the rotator cuff. A recent innovation is the reverse shoulder arthroplasty, which accommodates a deficient rotator cuff to allow better function of the shoulder after replacement.

Ankle arthroplasty remains the most common operation for arthritis, and is another area of new design. It presents a particular design challenge because the biological ankle has only 9 cm

Arthroplasties of the hip and/or knee have become common and successful surgical interventions for arthritis, and the need for them is growing with the population. It has been estimated that by 2030, the U.S. population will need 2.3 million knee replacements per year. “There's not enough manpower to do all that work,” said Dr. Bugbee. Technical skill is the single most important factor in success.

The appropriate patient age for joint replacement now ranges from the 40s through the 90s said Dr. Bugbee. Although the intervention was originally conceived to relieve pain for elderly, low-demand patients, it is now expected to bring both pain relief and functional improvement. But it is not without risk: Dr. Bugbee estimated that 90-day mortality after surgery is less than 1%, but deep vein thrombosis occurs in 10%-40% of cases. Dislocation rates are 0%-10% because of larger ball and socket joints. Dr. Bugbee estimated that infection occurs in 0.3%-3% of operations.

There are also functional limitations after joint replacement. “A good hip replacement is tantamount to a normal joint,” said Dr. Bugbee. “Unfortunately, the knee is not the same. It is a much more complex joint.”

One area of concern is biological response to implant materials. Microscopic wear debris can be shed by the articulating surfaces. The polyethylene plastic in some implants can cause a granulomatous response, and an osteolytic response in the bone. In metal-on-metal joints, a tiny amount of wear debris may cause severe early osteoarthritis. Ceramic-to-ceramic hip joints have a wear rate about 50 times less than that of conventional polyethylene joints, but they may squeak.

Direct-to-consumer advertising campaigns have promoted minimally invasive surgery, but smaller incisions are not correlated with better outcome, said Dr. Bugbee. They may even have a higher complication rate.

“The next innovation is so-called customized patient instrumentation,” said Dr. Bugbee. The surgery can actually be computer modeled in advance, and can incorporate instruments that are custom built to fit the individual patient's joints. The surgery is then more accelerated and more precise.

Moderator Dr. John J. Cush of Baylor University Medical Center in Dallas, asked, “When patients have bilateral knees, or right and left knees, one of the things I've noticed over the years [is that] they'll always say, 'My right (or my left) is the best one.' They always have an ipsilateral evaluation and a preference. Is there a good reason for that?”

“No. I've seen the same thing. I cannot for the life of me figure it out,” said Dr. Bugbee.

Disclosures: Dr. Bugbee disclosed research grants from Zimmer Inc., Smith & Nephew Inc., and Depuy Inc. Dr. Cush disclosed consulting fees or other remuneration from Centocor Inc., Abbott Laboratories, UCB, Pfizer Inc., Wyeth/Amgen, and Roche, and research grants from Genentech Inc., Pfizer, UCB, Roche, and Celgene Corp.

Major Finding: At week 52 in the IMPACT study, when all psoriatic arthritis patients were being treated with infliximab, 42% of patients achieved MDA; 96% of those who had achieved MDA had no signs of radiologic progression, vs. 67% of those who did not achieve MDA. In the IMPACT II study, comparing the 40% of patients who were in MDA at week 52 with those who were not showed that 78% and 57% showed no signs of radiologic progression.

Data Source: IMPACT study data for 63 patients with psoriatic arthritis and IMPACT II data for 157 similar patients. Both studies compared infliximab and placebo.

Disclosures: Arthritis Research UK funded the study. Dr. Coates said she has received speaker fees from Centocor/Schering-Plough.

BIRMINGHAM, ENGLAND — Radiologic damage is reduced in patients with psoriatic arthritis that is treated with anti–tumor necrosis factor if they meet new minimal disease activity criteria, according to Dr. Laura C. Coates.

This first, and only, composite measure developed for psoriatic arthritis could potentially be used as an objective target or outcome measure in clinical trials, Dr. Coates said at the meeting.

“Minimal disease activity is a concept that has been defined by the Outcome Measures in Rheumatoid Arthritis Clinical Trials group as a state of disease activity deemed a useful target of treatment by both the patient and physician, given current treatment possibilities and limitations,” explained Dr. Coates of the University of Leeds (England).

Dr. Coates and her associates have recently developed minimal disease activity (MDA) criteria for psoriatic arthritis using data on 40 patients with the disease and the expert opinions of 60 rheumatologists and dermatologists (Ann. Rheum. Dis. 2010;69:48-53).

For a patient to achieve MDA, five of the following seven criteria must be met:

▸ A tender joint count less than or equal to one.

▸ A swollen joint count less than or equal to one.

▸ A Psoriasis Area and Severity Index score less than or equal to 1 or a body surface area less than or equal to 3.

▸ A patient pain visual analog score (VAS) less than or equal to 15.

▸ A patient global activity VAS less than or equal to 20.

▸ A Heath Assessment Questionnaire score less than or equal to 0.5.

▸ A tender entheseal points count less than one.

Prior studies have shown that one-third of Canadian patients with psoriatic arthritis can consistently meet the new MDA criteria for more than 1 year, and that when they do, there is a lower rate of joint damage assessed using a clinical scoring system.

Dr. Coates presented the findings of a study that is now looking at the effects of achieving MDA on radiologic outcomes. Data on 220 patients in the IMPACT [Infliximab Multinational Psoriatic Arthritis Clinical Trial] and IMPACT II trials of infliximab therapy vs. placebo were used. Patients in these trials had active psoriatic arthritis and had failed treatment with at least one disease-modifying antirheumatic drug or NSAID. Radiologic progression in the hands and feet was found to be significantly less in patients who achieved MDA with infliximab therapy.

Looking at the data from the original IMPACT trial (n = 63), investigators found that 48% of patients treated with infliximab achieved MDA, compared with 3% of placebo patients (P less than .0001). At week 52, by which time all patients were being treated with the anti-TNF agent, 42% of patients achieved MDA, the majority (96%) of whom had no signs of radiologic progression, compared with two-thirds (67%) of those who did not achieve MDA (P = .012). After 104 weeks of follow-up, 30% were in MDA. None of those who achieved MDA had signs of radiologic progression, compared with 58% of those who did not achieve MDA.

In IMPACT II (n =157), 52% of infliximab patients and 21% of placebo patients achieved MDA after 24 weeks of study (P = .001). At 1 year, when all patients were receiving infliximab, 40% of patients were in MDA. Again, comparing the patients who were in MDA at week 52 with those who were not showed that 78% and 57% showed no signs of radiologic progression (P = .009).

“Around 40%-50% of patients with psoriatic arthritis can achieve MDA” with anti-TNF therapy, Dr. Coates said. She noted that the placebo response was low and that patients who achieve MDA “are more likely to halt their radiographic progression.”

A limitation of the study was that little radiographic progression occurred in the cohort of patients studied.

“This is the only composite disease activity measure that has been developed for psoriatic arthritis to date,” Dr. Coates said. “It encompasses measures of joint disease, skin disease, entheses, and patient-related outcomes, so it really does cover a wide variety of psoriatic disease.”

One of the advantages of using the measure, Dr. Coates noted, is that it can be used “cross-sectionally” and on any day to determine whether MDA is achieved. Furthermore, it confirms a satisfactory level of disease activity, not just a response to treatment, as the current American College of Rheumatology or Psoriatic Arthritis Response Criteria do.

The x-ray shows distal phalangeal joint damage from psoriatic arthritis.

Source © 2010 National Medical Slide Bank/Custom Medical Stock Photo, All Rights Reserved

Major Finding: At week 52 in the IMPACT study, when all psoriatic arthritis patients were being treated with infliximab, 42% of patients achieved MDA; 96% of those who had achieved MDA had no signs of radiologic progression, vs. 67% of those who did not achieve MDA. In the IMPACT II study, comparing the 40% of patients who were in MDA at week 52 with those who were not showed that 78% and 57% showed no signs of radiologic progression.

Data Source: IMPACT study data for 63 patients with psoriatic arthritis and IMPACT II data for 157 similar patients. Both studies compared infliximab and placebo.

Disclosures: Arthritis Research UK funded the study. Dr. Coates said she has received speaker fees from Centocor/Schering-Plough.

BIRMINGHAM, ENGLAND — Radiologic damage is reduced in patients with psoriatic arthritis that is treated with anti–tumor necrosis factor if they meet new minimal disease activity criteria, according to Dr. Laura C. Coates.

This first, and only, composite measure developed for psoriatic arthritis could potentially be used as an objective target or outcome measure in clinical trials, Dr. Coates said at the meeting.

“Minimal disease activity is a concept that has been defined by the Outcome Measures in Rheumatoid Arthritis Clinical Trials group as a state of disease activity deemed a useful target of treatment by both the patient and physician, given current treatment possibilities and limitations,” explained Dr. Coates of the University of Leeds (England).

Dr. Coates and her associates have recently developed minimal disease activity (MDA) criteria for psoriatic arthritis using data on 40 patients with the disease and the expert opinions of 60 rheumatologists and dermatologists (Ann. Rheum. Dis. 2010;69:48-53).

For a patient to achieve MDA, five of the following seven criteria must be met:

▸ A tender joint count less than or equal to one.

▸ A swollen joint count less than or equal to one.

▸ A Psoriasis Area and Severity Index score less than or equal to 1 or a body surface area less than or equal to 3.

▸ A patient pain visual analog score (VAS) less than or equal to 15.

▸ A patient global activity VAS less than or equal to 20.

▸ A Heath Assessment Questionnaire score less than or equal to 0.5.

▸ A tender entheseal points count less than one.

Prior studies have shown that one-third of Canadian patients with psoriatic arthritis can consistently meet the new MDA criteria for more than 1 year, and that when they do, there is a lower rate of joint damage assessed using a clinical scoring system.

Dr. Coates presented the findings of a study that is now looking at the effects of achieving MDA on radiologic outcomes. Data on 220 patients in the IMPACT [Infliximab Multinational Psoriatic Arthritis Clinical Trial] and IMPACT II trials of infliximab therapy vs. placebo were used. Patients in these trials had active psoriatic arthritis and had failed treatment with at least one disease-modifying antirheumatic drug or NSAID. Radiologic progression in the hands and feet was found to be significantly less in patients who achieved MDA with infliximab therapy.

Looking at the data from the original IMPACT trial (n = 63), investigators found that 48% of patients treated with infliximab achieved MDA, compared with 3% of placebo patients (P less than .0001). At week 52, by which time all patients were being treated with the anti-TNF agent, 42% of patients achieved MDA, the majority (96%) of whom had no signs of radiologic progression, compared with two-thirds (67%) of those who did not achieve MDA (P = .012). After 104 weeks of follow-up, 30% were in MDA. None of those who achieved MDA had signs of radiologic progression, compared with 58% of those who did not achieve MDA.

In IMPACT II (n =157), 52% of infliximab patients and 21% of placebo patients achieved MDA after 24 weeks of study (P = .001). At 1 year, when all patients were receiving infliximab, 40% of patients were in MDA. Again, comparing the patients who were in MDA at week 52 with those who were not showed that 78% and 57% showed no signs of radiologic progression (P = .009).

“Around 40%-50% of patients with psoriatic arthritis can achieve MDA” with anti-TNF therapy, Dr. Coates said. She noted that the placebo response was low and that patients who achieve MDA “are more likely to halt their radiographic progression.”

A limitation of the study was that little radiographic progression occurred in the cohort of patients studied.

“This is the only composite disease activity measure that has been developed for psoriatic arthritis to date,” Dr. Coates said. “It encompasses measures of joint disease, skin disease, entheses, and patient-related outcomes, so it really does cover a wide variety of psoriatic disease.”

One of the advantages of using the measure, Dr. Coates noted, is that it can be used “cross-sectionally” and on any day to determine whether MDA is achieved. Furthermore, it confirms a satisfactory level of disease activity, not just a response to treatment, as the current American College of Rheumatology or Psoriatic Arthritis Response Criteria do.

The x-ray shows distal phalangeal joint damage from psoriatic arthritis.

Source © 2010 National Medical Slide Bank/Custom Medical Stock Photo, All Rights Reserved

Major Finding: At week 52 in the IMPACT study, when all psoriatic arthritis patients were being treated with infliximab, 42% of patients achieved MDA; 96% of those who had achieved MDA had no signs of radiologic progression, vs. 67% of those who did not achieve MDA. In the IMPACT II study, comparing the 40% of patients who were in MDA at week 52 with those who were not showed that 78% and 57% showed no signs of radiologic progression.

Data Source: IMPACT study data for 63 patients with psoriatic arthritis and IMPACT II data for 157 similar patients. Both studies compared infliximab and placebo.

Disclosures: Arthritis Research UK funded the study. Dr. Coates said she has received speaker fees from Centocor/Schering-Plough.

BIRMINGHAM, ENGLAND — Radiologic damage is reduced in patients with psoriatic arthritis that is treated with anti–tumor necrosis factor if they meet new minimal disease activity criteria, according to Dr. Laura C. Coates.

This first, and only, composite measure developed for psoriatic arthritis could potentially be used as an objective target or outcome measure in clinical trials, Dr. Coates said at the meeting.

“Minimal disease activity is a concept that has been defined by the Outcome Measures in Rheumatoid Arthritis Clinical Trials group as a state of disease activity deemed a useful target of treatment by both the patient and physician, given current treatment possibilities and limitations,” explained Dr. Coates of the University of Leeds (England).

Dr. Coates and her associates have recently developed minimal disease activity (MDA) criteria for psoriatic arthritis using data on 40 patients with the disease and the expert opinions of 60 rheumatologists and dermatologists (Ann. Rheum. Dis. 2010;69:48-53).

For a patient to achieve MDA, five of the following seven criteria must be met:

▸ A tender joint count less than or equal to one.

▸ A swollen joint count less than or equal to one.

▸ A Psoriasis Area and Severity Index score less than or equal to 1 or a body surface area less than or equal to 3.

▸ A patient pain visual analog score (VAS) less than or equal to 15.

▸ A patient global activity VAS less than or equal to 20.

▸ A Heath Assessment Questionnaire score less than or equal to 0.5.

▸ A tender entheseal points count less than one.

Prior studies have shown that one-third of Canadian patients with psoriatic arthritis can consistently meet the new MDA criteria for more than 1 year, and that when they do, there is a lower rate of joint damage assessed using a clinical scoring system.

Dr. Coates presented the findings of a study that is now looking at the effects of achieving MDA on radiologic outcomes. Data on 220 patients in the IMPACT [Infliximab Multinational Psoriatic Arthritis Clinical Trial] and IMPACT II trials of infliximab therapy vs. placebo were used. Patients in these trials had active psoriatic arthritis and had failed treatment with at least one disease-modifying antirheumatic drug or NSAID. Radiologic progression in the hands and feet was found to be significantly less in patients who achieved MDA with infliximab therapy.

Looking at the data from the original IMPACT trial (n = 63), investigators found that 48% of patients treated with infliximab achieved MDA, compared with 3% of placebo patients (P less than .0001). At week 52, by which time all patients were being treated with the anti-TNF agent, 42% of patients achieved MDA, the majority (96%) of whom had no signs of radiologic progression, compared with two-thirds (67%) of those who did not achieve MDA (P = .012). After 104 weeks of follow-up, 30% were in MDA. None of those who achieved MDA had signs of radiologic progression, compared with 58% of those who did not achieve MDA.

In IMPACT II (n =157), 52% of infliximab patients and 21% of placebo patients achieved MDA after 24 weeks of study (P = .001). At 1 year, when all patients were receiving infliximab, 40% of patients were in MDA. Again, comparing the patients who were in MDA at week 52 with those who were not showed that 78% and 57% showed no signs of radiologic progression (P = .009).

“Around 40%-50% of patients with psoriatic arthritis can achieve MDA” with anti-TNF therapy, Dr. Coates said. She noted that the placebo response was low and that patients who achieve MDA “are more likely to halt their radiographic progression.”

A limitation of the study was that little radiographic progression occurred in the cohort of patients studied.

“This is the only composite disease activity measure that has been developed for psoriatic arthritis to date,” Dr. Coates said. “It encompasses measures of joint disease, skin disease, entheses, and patient-related outcomes, so it really does cover a wide variety of psoriatic disease.”

One of the advantages of using the measure, Dr. Coates noted, is that it can be used “cross-sectionally” and on any day to determine whether MDA is achieved. Furthermore, it confirms a satisfactory level of disease activity, not just a response to treatment, as the current American College of Rheumatology or Psoriatic Arthritis Response Criteria do.

The x-ray shows distal phalangeal joint damage from psoriatic arthritis.

Source © 2010 National Medical Slide Bank/Custom Medical Stock Photo, All Rights Reserved